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11 days old

Clinical Compliance Associate

Kelly Services
Jacksonville, FL 32232
**Clinical Compliance Associate**



Kelly Science and Clinical FSP is currently seeking a Clinical Compliance Associate (CCA) for a long-term engagement in Jacksonville with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.



**Summary:**



As part of a matrix team, Clinical Compliance partners with Healthcare Compliance (HCC), Clinical Operation Associates, and Research & Development Personnel and assists in ensuring all clinical and medical affairs activities are done in compliance with Good Clinical Practice (GCP) and HCC Policies.



**Responsibilities:**



+ The CCA will assist in the timely registration, maintenance, and oversight of clinical trials in accordance with operating procedures, company policies, and federal / international regulations, by supporting the maintenance of Clinical trials.gov.

+ Support internal company clinical quality assurance audits and external regulatory inspections and respond to those audits and inspections including CAPA plans, training, and procedure modification and implementation.

+ The CCA will assist in conducting final audits of Trial Master File/eTMF in conjunction with Clinical Operations Associates to ensure that the Trial Master File and electronic Trial Master File is audit ready and complete in accordance with company SOPs, GCP, and FDA regulations.

+ The CCA will provide administrative and consulting support to the Clinical Research Review Committee, Safety Review Committee, Investigator Initiated Studies, and Clinician Initiated Innovative Studies Program.

+ Assist Clinical Compliance Specialist with processing procedural documents in the document management system. Collaborate with Document Control to ensure that documents are processed efficiently in a timely manner.

+ The Clinical Compliance Specialist will assist in the completion of Third-Party Intermediary Due Diligence, Cross Border Activities and Clinical Totality Transactions to ensure they comply with Health Care & company Policy. The CCA will assist in ensuring that payments are consistent with Fair Market Value and that the transactions are compliant with companys Health Care Compliance policies.



**Qualifications:**



+ At least Bachelors degree with > 0.5 years OR Associate with at least 1-3+ years professional experience in Healthcare Compliance or Clinical Research environment with knowledge of compliant related areas, is highly preferred

+ Background may include Compliance, Finance, Sales and Marketing, Medical Affairs, Legal, Pharmacovigilance, Regulatory, Auditing or Science Discipline.

+ Experience in working in clinical trials/studies and working knowledge of Good Clinical Practices (GCP), highly desirable.

+ Excellent interpersonal, oral communication, organizational, problem-solving, and analytical and time management skills.

+ Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines

+ Aptitude for learning new systems with minimal direction.

+ Must be detail-oriented with ability to efficiently fact-check and find errors.






**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.






**Why Kelly** **** **Science & Clinical?**






Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.






**About Kelly** ****






At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.



Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-21 Expires: 2022-10-22

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Clinical Compliance Associate

Kelly Services
Jacksonville, FL 32232

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