Our FSP team is currently seeking a Sr. CRA 2 with 4+ years of monitoring residing in the Southeast US. WHAT YOU WILL DO You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards. Responsibilities: - Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned - - Responsible for all aspects of site management as prescribed in the project plans - General On-Site Monitoring - Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study - Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements - Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data - Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested - Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs - Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management - Assist with training of new employees, eg. co-monitoring - Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned - Perform other duties as assigned by management Requirements - University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) - 4+ years of Clinical Monitoring experience - 50-60% overnight travel The important thing for us is you are comfortable working in an environment that is: - Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. - Changing priorities constantly asking you to prioritize and adapt on the spot. - Teamwork and people skills are essential for the study to run smoothly. - Technology based. We collect our data directly into an electronic environment. Work Environment: - Work is performed in an office environment with exposure to electrical office equipment. - Frequent travel to clients/ site locations with occasional travel both domestic and international. Physical Requirements: - Ability to sit for extended periods and operate a vehicle safely. - Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. - Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. - Ability to access and use a variety of computer software developed both in-house and off-the-shelf. - Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. - Regular and consistent attendance. - Varied hours may be required. - Target Pay Range: $125 - $140K #LI - Remote Applications will be accepted on an ongoing basis. Learn more about our EEO & Accommodations request here.

We anticipate the application window for this opening will close on - 18 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 Bring your 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 that changes lives. CAS 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. 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. Primary Responsibilities - Provide technical, educational, clinical and sales support to assist the Region in meeting Cardiac Ablation Solutions sales and customer service objectives.   - Represents Medtronic CAS during ablations procedures to provide troubleshooting and other technical assistance - Receives technical inquiries by customers. Researches solutions to questions or problems (e.g., Catheter, Console, Generator support) - Educational Support - Educates and trains physicians, hospital personnel and office staff on technical matters relating to AFS products and related procedures. - One-on-one training sessions - In-service education programs - Seminars and/or outside symposiums - Assists RM and field training department in educating/training new Clinical Specialists and Account Managers - Provides training and resources for hospital staff to enable them to conduct training for their personnel - Sales Support - Updates sales representatives concerning procedure. Immediately notifies Account Manager regarding issues or problems requiring follow-up - Serves as effective Medtronic CAS representative to physicians and support staff regarding Medtronic CAS products, service and support - Promotes the safe and effective use of Medtronic CAS products and related procedures - Understands national, regional and territory sales objectives. Works in partnership with Account Manager to achieve exceed goals 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. We seek out and hire a diverse workforce at every level: We need fresh ideas and inclusive insights to continue to be an innovative industry leader —that’s why we make it a point to seek out, attract and develop employees who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients. To learn more about Inclusion & Diversity at Medtronic Click Here Must Have Minimum Requirements To be considered for this role, please ensure these minimum requirements are evident on your resume. - High School diploma PLUS a minimum 4 years of work experience in healthcare within an EP, Cath Lab setting or sales in cardiac field OR - Associate degree PLUS a minimum of 2 years of work experience in healthcare within an EP, Cath Lab setting or sales in cardiac field OR - Bachelor degree Preferred Qualifications: - Preference will be given to local qualified candidates and candidates with Medtronic experience - B.A./B.S. Degree in nursing, cardiovascular, life sciences, or technical discipline with minimum of four years’ work experience in cardiac field, hospital/clinic or sales - Pacing school/ATI-like training program in addition to BQs - Proven track record with technical training assignments - Experience in the cardiac catheter ablation field, EP lab, in a hospital/clinic or EP medical sales providing technical / clinical support Additional Job Requirements: - Environmental exposure to infectious disease and radiation - Clinical Specialists are required to be within their assigned territory each day to be available as unscheduled needs arise - Clinical Specialists will on occasion be required to travel outside of their assigned territory and possibility overnight - Must have a valid driver’s license - Ability to freely move throughout the facility, use a phone, keyboard and mouse, visually able to interact with personal computers - Must be able to stand/sit/walk for 8 hours a day - Must have a valid driver’s license - Must be able to drive approximately 75% of the time within assigned territory and may require overnight travel. 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. CARDIOVASCULAR PORTFOLIO:   Cardiac Ablation Solutions offers cardiac mapping and ablation solutions to treat patients with abnormal heart rhythms. Our vision is to help patients worldwide by advancing innovation for the diagnosis and ablation of cardiac arrhythmias, enabling clinicians to perform procedures with superior outcomes.  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):$75,000.00 - $85,000.00 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.

Sr CRA - Sponsor Dedicated - Oncology (Home-Based, Eastern US) 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 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 via review of site source documents and medical records. 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. - Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; 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 project 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, and may, with supervision, lead, 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. - May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned. - May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager. For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. 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 As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country 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 Identify operational efficiencies and process improvements Develop country level informed consent forms Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared Participate in bid defense meetings 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. Basic level of critical thinking skills expected. - Ability to manage required travel of up to 75% on a regular basis 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: $80,600.00 - $145,000.00 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.

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. We have an immediate need for a FREELANCE Serbian Speaking & English Speaking SrCRA to join us. The Senior Clinical Research Associate position is responsible for clinical monitoring for assigned protocols and investigational sites. The role is responsible for ensuring that studies are conducted and documented in accordance with the study protocol, standard operating procedures, Good Clinical Practices (GCP) and other applicable regulatory requirements. Main Responsibilities: - Responsible for conduct of all types of monitoring, and co-monitoring visits and associated monitoring activities for assigned clinical sites both in person, and remote. This includes evaluation, site initiation, interim and close out monitoring visits. Responsible for monitoring report writing and completion within required SOP and local regulatory parameters. - Ex-US: May be responsible for performing study start up activities in accordance with local practice, including site identification and feasibility activities, collection and preparation of site essential documents, Ethics Committee submissions, and other site set up activities. - Support development of study specific documentation related to monitoring activities as assigned. This includes but is not limited to monitoring trackers, clinical monitoring guidelines, clinical monitoring plan, source document templates, site tools, and worksheets, etc. Responsible for site personnel management and training on the protocol requirements, proper source documentation procedures compliance, and case report completion requirements. - Review source document and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues. - Manage, prepare, send, track, and return investigational supplies as assigned. Includes monitoring and documenting investigational supplies dispensing, inventory, and reconciliation. - Monitor assigned clinical trials and clinical sites by reviewing and reporting site enrollment, and termination updates, monitoring visits, protocol deviations, serious adverse events, laboratory abnormalities and any other activity at the site that contributes to proper conduct of the clinical trial per protocol, and regulatory requirements. - Review and oversee regulatory documentations for accuracy and completeness and support assigned clinical sites with any regulatory concerns as appropriate. - Communicate with assigned clinical sites, investigators, site personnel, client personnel, and any other cross functional team member involved in the assigned clinical trials to address any study needs related to the monitoring and site management activities as assigned. - Participate in meetings and conference calls with internal project teams, Sponsor teams, and any external partners working on execution of the assigned clinical trial. Necessary Skills and Abilities: - Excellent verbal, written communication skills and interpersonal and presentation skills are required. - Excellent computer skills with experience using Microsoft Office (Outlook, Word, Excel, and Power Point) applications to prepare charts, tables, forms, reports, and presentations required. - Electronic data capture (EDC), CTMS, IVRS, and eTMF experience required. - Knowledge of applicable local law, local regulatory requirements and regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials. - Must be able to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision. - Must be able to offer solutions when obstacles are identified and train as necessary to achieve project goals. - Must have a general understanding of routine project goals from an organizational perspective. - Strong organizational skills and attention to details required. Ability to prioritize and plan workload is essential. Educational Requirements: - Bachelor's degree or equivalent combination of education and experience. Experience Requirements: - > 5 years of experience as a Clinical Research Associate. #EL-LI1 #LI-REMOTE We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***