Presence logo
Presence

Empowering all who serve children with diverse needs

Clinical Research Associate

Clinical ResearchClinical ResearchFull TimeRemoteSeniorTeam 51-200Since 2009H1B SponsorCompany SiteLinkedIn

Location

North Carolina

Posted

87 days ago

Salary

0

Seniority

Senior

No structured requirement data.

Job Description

Clinical Research Associate

Presence

Clinical Research Associate Location: Morrisville United States Job Description: Description Experienced Clinical Research Associate - Full-Service - Oncology Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health - We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities - Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements - Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications: - Bachelor's degree or RN in a related field or equivalent combination of education, training and experience - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements - Must demonstrate good computer skills and be able to embrace new technologies - Excellent communication, presentation and interpersonal skills - Ability to manage required travel of up to 75% on a regular basis - US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.

Related Categories

Related Job Pages

More Clinical Research Jobs

Presence logo

Clinical Research Associate

Presence

Empowering all who serve children with diverse needs

Full TimeHybridTeam 51-200Since 2009H1B Sponsor

Clinical Research Associate - Full-Service - Oncology Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health - We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities - Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements - Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications: - Bachelor's degree or RN in a related field or equivalent combination of education, training and experience - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements - Must demonstrate good computer skills and be able to embrace new technologies - Excellent communication, presentation and interpersonal skills - Ability to manage required travel of up to 75% on a regular basis - US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.

North Carolina
Full TimeRemoteTeam 10,001+Since 1949H1B Sponsor

We anticipate the application window for this opening will close on - 26 Mar 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life We are seeking a committed professional to join our team. While this is a remote position not located at a physical Medtronic site, the candidate hired will be required to reside within the territory and drive to multiple accounts throughout the region. A valid driver's license is essential for this role.Bring your clinical talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentorship, and guidance you need to own your future success. Join us for a career in clinical and sales support as we engineer the extraordinary and change lives. POSITION DESCRIPTION: Provide technical, educational and sales support to assist the district in meeting assigned Coronary Renal Denervation (CRDN) sales and customer service objectives with a heavy emphasis on supporting CathWorks FFRangio. CRDN seeks collaborative candidates who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients. We look for candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action. This position will be the customer's first line contact for the CRDN daily operations at assigned accounts. ** This position is a field-based and regional role. Must be able to travel up to 70% of the time within regions** To find all CRDN Clinical Specialist roles available please use #CRDNCS in the key word search at Medtronic Careers. POSTION RESPONSIBILITIES: - Sales Support for CRDN business units and will assist with the implementation of the sales strategy of the remaining CRDN business units. - Support the regional CRDN sales strategy as set forth by the National Sales Director; working with sales representatives and managers of all business units to achieve business plans. - The Clinical Specialist Manager (CSM) and National Sales Director may include primary responsibility for sales if no other sales representative is assigned to the business unit. Technical Support: - Represents Medtronic during procedures and implants of products to provide troubleshooting and other technical assistance. - Receives technical inquiries by telephone. Research solutions to questions or problems (e.g. product selection issues, technical questions about Medtronic CRDN products when appropriate, etc.) Educational Support: - Educates and trains physicians, hospital personnel and office staff on technical matters relating to our products and pacing through conducting and/or coordinating: - 1. One-on-one training sessions - 2. In-service education programs - 3. Seminars and/or outside symposiums - Assist DM, CSM and in-house training department in educating/training new Clinical Specialists and sales representatives. - Provide training and resources for hospital staff to enable them to conduct training for their personnel (“train the trainer”). Sales Support: - During/following cases: - Complete necessary documentation and phone calls (customer service). - Update sales representatives concerning cases. Immediately notifies representatives regarding issues or problems requiring follow-up. - Serves as effective Medtronic representative to physicians and support staff regarding Medtronic products, service, and support. - Maintain current knowledge regarding CRDN, Medtronic programs, products and services and competitive products. - Maintains open, effective communication with all district personnel, customers, and other Medtronic employees - Performs other related duties as assigned BASIC QUALIFICATIONS: IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME - High School Diploma and a minimum 8 years of work experience in healthcare, field sales or work experience utilizing complex mathematics, mechanical concepts, science, or computing - OR- - Associate degree and a minimum 6 years of work experience in the healthcare, field sales or work experience utilizing complex mathematics, mechanical concepts, science, or computing - OR- - Bachelor’s Degree plus 4 years of experience. DESIRED/PREFERRED QUALIFICATIONS (optional): - Relevant industry, healthcare, industry, marketing, or medical education experience considered where there is specific focus on awareness and education or medical project management.  - Expertise with Microsoft Outlook, Excel, Word and PowerPoint and system tracking.    - Strong project management skills and experience coordinating and executing marketing programs.  - Excellent interpersonal, written, and verbal communication skills.  - Excellent work ethic   - Thorough working knowledge of medical terminology, medical procedures, and the medical device industry.  - Excellent customer service skills and problem resolution skills.  - Ability to effectively build and maintain positive relationships with peers and colleagues across organizational levels.  PHYSICAL JOB REQUIREMENTS: - Continuous verbal and written communication. - Frequent 2-handed lifting of up to 40 lbs. from floor to chair/table and from one to another surface at approximately the same level - Sitting, standing and/or walking for up to eight plus hours per day - Environmental exposures include eye protection, infectious disease and radiation - Ability to wear 7-9 lbs of lead for extended periods of time while in the O.R. - Frequently required to use hands to finger, handle or feel objects, tools or controls - Ability to effectively use a mobile phone, PC, keyboard and mouse - Frequent bending/stooping, squatting and balance - Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus in relation to travel and operating a personal computer - Ability to travel extensively with ease - Must be able to drive approximately 80% of the time within assigned territory - Environmental exposure to infectious disease and radiation - Must have a valid driver's license and active vehicle insurance policy.  In addition, your driving record will be reviewed and will be considered as part of your application For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.  The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$100,000 - $100,000 The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). In addition to Base Salary, this position is eligible for a Sales Incentive Plan (SIP), which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

United States
Job Closed
Full TimeRemoteTeam 501-1,000H1B No Sponsor

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient’s immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. • Work with a collaborative team with the ability to work across different areas of the company. • Ability to join a growing company with professional development opportunities. Position Summary IB Temporary - Senior CRA, Field Monitor will participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support. Essential Functions - Develop, review and update study-related training materials and documents including: site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals - Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods etc. - Communicate scientific rationale for assigned studies to team members and clinical sites - Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements - Create/edit, distribute and collect site feasibility questionnaires - Oversee and support collection of essential documents during study start-up - Collect study and site metrics and maintain study trackers, as needed - Participate in case report form (CRF) data review and review of source documents, work with sites to resolve data queries as needed - Communicate regularly with field and in-house Clinical Research Associates (CRAs) to provide information before and after site visits - Partner with field CRAs to resolve issues identified during site visits - Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) to properly conduct the trial as well as resolve IP temperature monitoring excursions and train or assist sites with corrective actions - Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues - Clinical specimen log review, coordinating shipment of specimens to the sponsor or contracted vendor - Conduct remote monitoring tasks including reconciliation of site investigational product accountability, as needed - Provide mentorship and training to newly hired research staff. - Performs other duties as assigned. Education & Experience - Bachelor’s degree in a clinical research, science, or health-related field with 6 years of experience in a clinical research setting required; or - High school diploma with 8 years of experience in a clinical research setting required - Minimum of 2 years’ experience as a Clinical Research Associate II or higher required Knowledge, Skills, & Abilities - Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe - Excellent written/oral communication skills as well as strong organizational and multi-tasking skills - Strong organizational and multi-tasking skills - Understand the job-specific system, processes as defined by the company’s SOPs, and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager. - Maintain corporate confidentiality at all times - Ability to set priorities and independent decision making - Ability to work independently as well as in teams - Ability to discover issues, provides solutions and provides guidance to in-house team on how to address issues - Strong oral and written communication skills - Outgoing and confident demeanor - Independent thinker and persuasive communicator - Detail oriented, with solid organization and time management skills - Completes projects with reliability and minimal guidance - Knowledge of drug development process - Computer literacy: EDC, eTMF, CTMS, etc. - Working knowledge of ICH E6, and the Code of Federal Regulations Working Environment / Physical Environment - Must be able to travel up to 75% of the time based on study requirements - Remote with ability to work flexible hours for various time zones The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location. National Market (all markets unless identified as Premium) $61.54 (entry-level qualifications) to $65.38 (highly experienced) per hour Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston) $63.94 (entry-level qualifications) to $67.31 (highly experienced) per hour The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

United States
$62 - $67 / hour
Full TimeRemoteTeam 10,001+Since 1949H1B Sponsor

We anticipate the application window for this opening will close on - 31 Mar 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life We are seeking a committed professional to join our team. While this is a remote position not located at a physical Medtronic site, the candidate hired will be required to reside within the territory and drive to multiple accounts throughout the region. A valid driver's license is essential for this role.Bring your clinical talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentorship, and guidance you need to own your future success. Join us for a career in clinical and sales support as we engineer the extraordinary and change lives. POSITION DESCRIPTION: Provide technical, educational and sales support to assist the district in meeting assigned Coronary Renal Denervation (CRDN) sales and customer service objectives with a heavy emphasis on supporting CathWorks FFRangio. CRDN seeks collaborative candidates who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients. We look for candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action. This position will be the customer's first line contact for the CRDN daily operations at assigned accounts. ** This position is a field-based and regional role. Must be able to travel up to 70% of the time within regions** To find all CRDN Clinical Specialist roles available please use #CRDNCS in the key word search at Medtronic Careers POSTION RESPONSIBILITIES: - Sales Support for CRDN business units and will assist with the implementation of the sales strategy of the remaining CRDN business units. - Support the regional CRDN sales strategy as set forth by the National Sales Director; working with sales representatives and managers of all business units to achieve business plans. - The Clinical Specialist Manager (CSM) and National Sales Director may include primary responsibility for sales if no other sales representative is assigned to the business unit. Technical Support: - Represents Medtronic during procedures and implants of products to provide troubleshooting and other technical assistance. - Receives technical inquiries by telephone. Research solutions to questions or problems (e.g. product selection issues, technical questions about Medtronic CRDN products when appropriate, etc.) Educational Support: - Educates and trains physicians, hospital personnel and office staff on technical matters relating to our products and pacing through conducting and/or coordinating: - 1. One-on-one training sessions - 2. In-service education programs - 3. Seminars and/or outside symposiums - Assist DM, CSM and in-house training department in educating/training new Clinical Specialists and sales representatives. - Provide training and resources for hospital staff to enable them to conduct training for their personnel (“train the trainer”). Sales Support: - During/following cases: - Complete necessary documentation and phone calls (customer service). - Update sales representatives concerning cases. Immediately notifies representatives regarding issues or problems requiring follow-up. - Serves as effective Medtronic representative to physicians and support staff regarding Medtronic products, service, and support. - Maintain current knowledge regarding CRDN, Medtronic programs, products and services and competitive products. - Maintains open, effective communication with all district personnel, customers, and other Medtronic employees - Performs other related duties as assigned BASIC QUALIFICATIONS: IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME  - High School Diploma and a minimum 8 years of work experience in healthcare, field sales or work experience utilizing complex mathematics, mechanical concepts, science, or computing - OR- - Associate degree and a minimum 6 years of work experience in the healthcare, field sales or work experience utilizing complex mathematics, mechanical concepts, science, or computing - OR- - Bachelor’s Degree and 4 years of experience DESIRED/PREFERRED QUALIFICATIONS (optional): - Relevant industry, healthcare, industry, marketing, or medical education experience considered where there is specific focus on awareness and education or medical project management.  - Expertise with Microsoft Outlook, Excel, Word and PowerPoint and system tracking.    - Strong project management skills and experience coordinating and executing marketing programs.  - Excellent interpersonal, written, and verbal communication skills.  - Excellent work ethic   - Thorough working knowledge of medical terminology, medical procedures, and the medical device industry.  - Excellent customer service skills and problem resolution skills.  - Ability to effectively build and maintain positive relationships with peers and colleagues across organizational levels.  PHYSICAL JOB REQUIREMENTS: - Continuous verbal and written communication. - Frequent 2-handed lifting of up to 40 lbs. from floor to chair/table and from one to another surface at approximately the same level - Sitting, standing and/or walking for up to eight plus hours per day - Environmental exposures include eye protection, infectious disease and radiation - Ability to wear 7-9 lbs of lead for extended periods of time while in the O.R. - Frequently required to use hands to finger, handle or feel objects, tools or controls - Ability to effectively use a mobile phone, PC, keyboard and mouse - Frequent bending/stooping, squatting and balance - Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus in relation to travel and operating a personal computer - Ability to travel extensively with ease - Must be able to drive approximately 80% of the time within assigned territory - Environmental exposure to infectious disease and radiation - Must have a valid driver's license and active vehicle insurance policy.  In addition, your driving record will be reviewed and will be considered as part of your application.   For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.  The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$100,000 - $100,000 In addition to Base Salary, this position is eligible for a Sales Incentive Plan (SIP), which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. Learn more about total rewards here. https://www3.benefitsolver.com/benefits/BenefitSolverView?DO_NUM=182665432&error_page=errorpage&page_name=public/download_document¤t_page=admin/refcenter/index&session_co_num=30601&CSRF=aa8b608e81c0aa2acc1346278c504be7963ad2607c15b238282af8d3b5ef0007 The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

United States
Job Closed