The World Leader In Serving Science
CRA II/ Senior CRA
Location
United States
Posted
100 days ago
Salary
0
Seniority
Senior
No structured requirement data.
Job Description
CRA II/ Senior CRA
Thermo Fisher Scientific
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. What You’ll Do: • Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. • Participates in investigator meetings as necessary. Identifies potential • investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System). • Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. • Responds to company, client and applicable regulatory requirements/audits/inspections. • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. • Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. • Contributes to other project work and initiatives for process improvement, as required. Education and Experience Requirements: • Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. • Valid driver's license where applicable. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Proven clinical monitoring skills • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving • Ability to manage Risk Based Monitoring concepts and processes • Good oral and written communication skills, with the ability to communicate effectively with medical personnel • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues • Good organizational and time management skills • Effective interpersonal skills • Attention to detail • Ability to remain flexibile and adaptable in a wide range of scenarios • Ability to work in a team or independently as required • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software • Good English language and grammar skills • Good presentation skills Working Conditions and Environment: • Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. • Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays. • Exposure to biological fluids with potential exposure to infectious organisms. • Personal protective equipment required such as protective eyewear, garments and gloves. • Exposure to fluctuating and/or extreme temperatures on rare occasions
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We anticipate the application window for this opening will close on - 16 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. At Medtronic, the Senior Clinical Specialist, supports the Neuromodulation Pain, Target Drug Delivery and Interventional Therapies in the areas of surgical coverage, follow-up support, troubleshooting, customer service and education. This person will be engaged in basic market development activities depending upon the needs of the assigned territory and district. This is a field based role. We are seeking a committed professional, required to reside within the territory and drive to multiple accounts throughout the region, to join our winning team. A valid driver's license is essential for this role, which also includes travel outside the territory, presenting opportunities for broader engagement. Responsibilities may include the following and other duties may be assigned: - Represents Medtronic as device specialist during surgical procedures by ensuring all necessary equipment and products required are available, providing technical support and device selection, and performing programming and testing of all device systems - Manages patients through all phases of the clinical process as well as educate them on the features and benefits of Medtronic products - Provides clinical support in surgeries, re-programmings, trouble-shooting and follow ups in hospitals and clinics - Educates and trains physicians, hospital personnel and office staff on products and therapies. This is expected by, but not limited to, coordinating one on one teaching sessions, formal in-services, education programs, seminars and/or outside symposia (based off quarterly Plan of Action as directed by Leadership) - Responds promptly and professionally to device-related inquiries by customers and patients - Ability to be flexible with schedule while working and/or attending clinical events, possibly outside of normal business hours to include weekends and after hours and at the discretion of Clinical Specialist Manager - Adheres to company policies and complies with required event reporting and documentation, utilizing Medtronic technology tools - Responsible for managing inventory provided for case coverage, including: timely transactions when product is used, sold or transferred, maintaining a required level of cycle count accuracy, executing product retrievals as instructed, turning over inventory in a reasonable time frame, not implanting expired product or product that is on hold - Contributes to the achievement of quarterly goals associated with specific initiatives at the district, regional and/or national level by partnering with colleagues and communicating effectively and regularly with Leadership - Maintains a working knowledge of competitive products - Regularly visits accounts to establish/maintain relationships with office staff and Health care providers - Accountable for placing orders with customer service for pending purchase orders and product replacement - Expected to work with materials management to collect POs for cases covered within the territory/district - Ensures personal understanding of all quality policies/system items that are personally applicable - Assists Management and Sales Training department in education/training of new employees within the district - Effectively utilizes Excel, a mobile phone, an IPAD, a laptop, and/or a Samsung tablet regularly - Manages business expenses and budget effectively and in given timeframe - Functions as a clinical leader within their territory and district, illustrating a high degree of autonomy and expert clinical acumen - Key contact for complex case coverage and troubleshooting - Is active in territory business planning and aligns activities to support sales objectives - Acts as a field trainer - Mentors fellow Associate Clinical Specialists and Clinical Specialists - Completes all new hire therapy trainings as directed by medical education - Completes all corporate compliance training prior to date due - Travels to cover district cases as needed 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 Qualifications Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. - A High School Diploma or GED with a minimum of 8 years of clinical or medical sales experience; or - An Associate Degree with a minimum of 6 years of clinical or medical sales experience; or - A Bachelor’s degree with a minimum of 4 years of clinical or medical sales experience. Nice to Have: Preferences - Bachelor's degree in a health care related field - Master’s degree - Registered nurse or HCP with experience in a sterile environment - Clinical experience with implantable neurological products and patient care - Experience in servicing medical personnel on product use - Experience with a medical device company or pharmaceutical company, and clinical experience in a specialty area: neurology, neurosurgery, orthopedic, operating room, pain management, or home health care - Understands basic reimbursement and healthcare environment - Excellent organizational skills and ability to work under pressure Additional Job Requirements: • Required to function using healthcare universal precautions to minimize exposure to infectious disease and radiation • Ability to serve as the primary resource for scheduled and unscheduled clinical events, periodically required to work weekends, evenings and nights and may be required to engage in overnight travel within own district or neighboring districts • Ability to work efficiently and autonomously with little direction when outside of clinical events • Ability to attend national meetings, district meetings and other training as requested • Ability to wear a 7-9 lbs protective lead apron for extended periods of time in the operating room • Ability to lift up to 40 lbs • Ability to sitting, standing, and/or walking for 8+ hours per day • Ability to bend/stoop, squat and balance frequently • 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. **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. Business Description: Our vision is to become the undisputed world leader in Neuromodulation, improving patient lives through innovative solutions. Our therapies span the care continuum; from early interventional procedures to implantable surgical technologies that relieve pain, restore function and improve lives for our patients. We're committed to applying clinical and economic evidence and integrated technologies to our unmatched portfolio of therapies to develop healthcare solutions that increase patient access, improve the efficiency of procedures and deliver successful patient outcomes. The Neuromodulation Operating Unit offers solutions — from early interventional procedures to implantable surgical technologies — that treat chronic pain as well as pain from spinal fractures, cancer, and severe spasticity. Our key Pain Therapies include: Spinal Cord Stimulation, Drug infusion for Chronic Pain / Drug infusion for severe Spasticity, and RF Nerve Ablation. Our key Interventional Therapies include: Balloon Kyphoplasty, Vertebroplasty, RF Ablation (for bone) and Microwave Ablation (for soft tissue). Click here to learn more about our entire Neurological product portfolio. 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):$88,000.00 - $132,000.00 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.
We anticipate the application window for this opening will close on - 3 Apr 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.At Medtronic, the Senior Clinical Specialist supports the Pelvic Health groups in the areas of surgical coverage, follow-up, support, troubleshooting, customer service and education within a territory. In certain instances, this role may be engaged in basic market development activities depending upon the needs of the assigned territory. This is a field-based role. We are seeking a committed professional to join our team, required to reside within the territory and drive to multiple accounts throughout the region. A valid driver's license is essential for this role, which also includes travel outside the territory, presenting opportunities for broader engagement. Responsibilities may include the following and other duties may be assigned. - Represents Medtronic Pelvic Health during surgeries and implants by providing all necessary equipment and products required for the implant, demonstrates expertise in all aspects of implant, follow-up support and troubleshooting techniques (such as proper device selection, appropriate programming, correct implantation and testing of all device systems). - Maintains current knowledge about assigned products and services as well as competitive products. - For new and existing accounts, this position is able to proactively identify needs and teach a broader level of caregivers and account employees. - Educates and trains physicians, hospital personnel and office staff on technical matters relating to our products and therapies. This is achieved by coordinating: one on one sessions, in service education programs, seminars and/or outside symposiums. - Assists district manager and in-house training department in education/training of new employees in the district (therapy consultants, clinical specialists, field clinical engineers, etc.). - Provides sales support during or following cases such as completing the necessary documentation (for example: implant registration, temporary id cards, packing list) and is able to execute invoices in a variety of different situations. This position is able to place an order with customer service for pending purchase orders and product replacement. - Maintains open and effective communication with all district personnel, customers and other Medtronic employees. - Contributes to the completion of milestones associated with specific projects at the regional and/or national level. - Has an understanding of all quality policy/system items that are applicable. - Follows all work/quality procedures to ensure quality system compliance and high-quality work. - Performs other related activities, as assigned. 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 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. 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. Qualifications: Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident on your resume. - High School Diploma or GED AND a minimum of 8 years of patient care/clinical experience; or - Associate’s Degree AND a minimum of 6 years of patient care/clinical experience; or - Bachelor’s Degree AND a minimum of 4 years of patient care/clinical experience. Nice to Have: - Bachelor’s or Master’s Degree - Clinical skill and knowledge (ex. ability to conduct a simple trial, implant and/or refill a pump) - Clinical experience with implantable Neuromodulation products and stim experience - Experience in servicing medical personnel on product use - Experience working with a medical device or pharmaceutical company and clinical experience in a specialty area: urology, surgical, RN, neurology, neurosurgery, orthopedic, operating room, or home health care - Ability to communicate effectively with sales and health care professionals - Ability to coach others on use of products and clinical applications - Excellent organizational skills - Ability to prioritize under pressure - Ability to manage multiple tasks simultaneously **Preference will be given to local qualified candidates and candidates with Medtronic experience Additional 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. - 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. Business Description: Pelvic Health is part of the Neuroscience Portfolio. Our therapies treat patients suffering from overactive bladder, non-obstructive urinary retention and fecal incontinence with our sacral neuromodulation (SNM) systems InterStim X™️ and InterStim™️ Micro; and our percutaneous tibial neuromodulation (PTNM) system NURO™️. More than 400 million people worldwide have incontinence, and many of them limit their lives socially, professionally and personally because of their condition. Our goal is to expand access to our therapies so we can help potentially millions of people get their lives back Click here to learn more about products. 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):88000-110000-132000 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.
Experienced Clinical Research Associate
Medpace, Inc.Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Our European clinical activities are growing rapidly, and we are currently seeking full-time, home-based Clinical Research Associates to join our Clinical Monitoring team, in the country of Georgia. This position will be instrumental in growing the team in Georgia and accomplishing tasks and projects that are vital to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. The Clinical Research Associate at Medpace is offered the unique opportunity to be involved at every stage of the drug development process by providing unrivalled support to our customers. If you want an exciting career where you use your medical or health background and education, travel extensively and are instrumental in the clinical trials process, this could be the opportunity for you. Our successful Clinical Research Associates possess varied backgrounds in the medical and related healthcare fields. Individuals who have succeeded in the CRA role include Registered Nurses, Dieticians, Pharmacists, Faculty of Science Graduates and Research Assistants. An extensive training program provides the platform to carry out your duties effectively and confidently. Please note that this role is not US based and you must be located in the country of Georgia to be considered. Responsibilities - Conduct pre-study, initiation, monitoring, and closeout visits for research sites - Perform source document verification and case report form review - Perform regulatory document review - Conduct study drug inventory - Perform adverse event and serious adverse event reporting and follow-up; and - Assess patient recruitment and retention Qualifications - Minimum a Bachelor of science in health-related field, MD or equivalent - Minimum of 1 year independent CRA monitoring - Broad knowledge of medical terminology and clinical patient management - Basic knowledge of drug therapy techniques and clinical research methodologies - Comprehensive knowledge of Local Regulations and ICH GCP - Excellent oral and written communication skills - Fluency in Georgian and English - Great attention to detail - Must hold a valid driver’s license - We kindly ask to submit applications in English Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks - Flexible work environment - Competitive compensation and benefits package - Competitive PTO packages - Structured career paths with opportunities for professional growth - Company-sponsored employee appreciation events - Employee health and wellness initiatives Awards - Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, 2024 and 2025 - Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
This position is a remote position with the expectation that you will work EST/CST hours to meet the government client's needs. Candidates must reside in the continental United States, Hawaii, Alaska, or Puerto Rico. Executes assigned clinical and operational projects within the Military & Family Life Counseling (MFLC) Program, including government‑directed ad hoc requests and internal program initiatives. Uses clinical knowledge and project management expertise to support compliant, high‑quality counseling service delivery while coordinating cross‑functional resources, managing risks, and tracking project progress. Provides routine project status updates, risk assessments, and recommendations to program leadership to support informed decision‑making. - Project Execution and Delivery Management: Leads day-to-day execution of assigned clinical and program-related projects by defining scope, deliverables, milestones, and success criteria that reflect clinical, operational, and contractual requirements. Develops and maintains project plans and schedules; coordinates cross-functional resources, including clinical subject matter experts; and manages risks, issues, and scope changes with particular attention to clinical considerations such as protocol adherence, documentation standards, and privacy requirements. Monitors progress and drives timely resolution of challenges to ensure projects are delivered on schedule and to quality standards. (35%) - Project Planning & Portfolio Support: Supports the execution of assigned MFLC projects within the broader project portfolio by applying clinical and programmatic knowledge to project planning and prioritization activities. Maintains accurate and timely project information within established project management tools, ensuring assigned initiatives are properly scoped, tracked, and aligned with contractual requirements, clinical standards, and program priorities. Applies sound judgment informed by counseling practice, service delivery considerations, and contract requirements to identify issues, recommend actions, and escalate risks that may impact service quality or project outcomes. (30%) - Stakeholder Engagement & Cross-Functional Coordination: Partners with program leadership, operations, clinical teams, and other cross-functional stakeholders to support project alignment, readiness, and execution. Facilitates working sessions, status discussions, and task coordination to ensure shared understanding of project objectives, roles, and timelines. Supports change implementation by coordinating training materials, job aids, and workflow documentation, helping counseling and program staff understand and adopt project-related changes while maintaining high-quality service delivery. (15%) - Compliance, Risk & Contract Alignment: Supports compliance with government contract requirements, clinical standards, privacy regulations, and organizational policies across assigned projects. Proactively identifies and documents risks related to clinical quality, service delivery, or contractual compliance; tracks mitigation actions; and escalates concerns to appropriate clinical or program leadership with clear analysis and recommended next steps. Coordinates with quality, compliance, and clinical teams as needed to support reviews, audits, or corrective actions. (10%) - Performance Analytics, Reporting & Continuous Improvement: Tracks and reports on assigned project performance using established metrics such as milestone completion, deliverable acceptance, and readiness indicators. Prepares routine project status updates and summaries for program leadership and stakeholders, highlighting risks, dependencies, and potential service impacts. Contributes to continuous improvement efforts by documenting lessons learned, identifying opportunities to improve project execution practices, and supporting enhancements to clinical and service delivery processes. (10%) Other Job Requirements Responsibilities 7+ years of experience supporting clinical operations, behavioral health programs, or health services delivery in a regulated or government‑contracted environment. 5+ years of progressive project management experience, including responsibility for planning, executing, and closing complex, cross‑functional projects. Demonstrated project management experience within health services, clinical programs, or human services environments. Proven ability to plan, organize, schedule, coordinate, and monitor project activities across multiple stakeholders and workstreams. Ability to manage multiple concurrent projects and priorities in a high-tempo, deadline‑driven environment. Familiarity with clinical standards, documentation expectations, privacy requirements (e.g., HIPAA or equivalent), and government contract compliance considerations. Demonstrated ability to communicate effectively with clinical professionals, operations teams, and program leadership to coordinate complex project activities. General Job Information Title Senior Clinical Project Manager, MFLC Grade 27 Work Experience - Required Clinical, Project/Program Management Work Experience - Preferred Education - Required Master's - Clinical Psychology, Master's - Counseling, Master's - Mental Health Services, Master's - Psychology, Master's - Social Work Education - Preferred License and Certifications - Required LCSW - Licensed Clinical Social Worker - Care Mgmt, LMFT - Licensed Marital and Family Therapist - Care Mgmt, LMHC - Licensed Mental Health Counselor - Care Mgmt, LPC - Licensed Professional Counselor - Care Mgmt, PSY - Psychologist - Care Mgmt License and Certifications - Preferred PMP - Project Management Professional - Enterprise Salary Range Salary Minimum: $77,785Salary Maximum: $124,455 This information reflects the anticipated base salary range for this position based on current national data. Minimums and maximums may vary based on location. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors permitted by law. This position may be eligible for short-term incentives as well as a comprehensive benefits package. Magellan offers a broad range of health, life, voluntary and other benefits and perks that enhance your physical, mental, emotional and financial wellbeing. Magellan Health, Inc. is proud to be an Equal Opportunity Employer and a Tobacco-free workplace. EOE/M/F/Vet/Disabled. Every employee must understand, comply with and attest to the security responsibilities and security controls unique to their position; and comply with all applicable legal, regulatory, and contractual requirements and internal policies and procedures.


