13 days old

Clinical Research Quality Control Specialist

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

_Kelly Services is currently seeking a International Regulatory Affairs Specialist for a long-term engagement with one of our Global Pharmaceutical client._

_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 may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time._

**Job Description**

+ 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.

+ Assist in the completion of Third-Party Intermediary Due Diligence, Cross Border Activities and Clinical Totality Transactions to ensure they comply with HCC and JJV Policy.

+ Assist in ensuring that payments are consistent with Fair Market Value and the transactions are compliant with HCC and JJV policies.

+ Assist in providing training to contractors and employees on third party Intermediaries and Investigators on JJV HCC, Business Integrity Policies and Foreign Corrupt Practices Act (FCPA).

+ Assist in the timely registration, maintenance, results disclosure, and oversight of clinical trials in clinical trial database (i.e. accordance with operating procedures, company policies, and federal and international regulations.

+ 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.

+ Conduct quality review of Trial Master File (TMF) in conjunction with Clinical Operations Associates to ensure that the TMF is audit ready and complete in accordance with company SOPs, GCP, and FDA regulations.


+ 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.

+ Ability to understand and manage HCC program elements within complex organizational structure, business situations and develop solutions to ensure compliant growth is achieved.

+ Experience in working in clinical 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** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you 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 is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (


Posted: 2022-01-14 Expires: 2022-02-24

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Clinical Research Quality Control Specialist

Kelly Services
Jacksonville, FL 32232

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