Clinical Compliance Associate Jobs

Clinical Compliance Associate:

• 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.
• 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 & client Policy. The CCA will assist in ensuring that payments are consistent with Fair Market Value and that the transactions are compliant with our client's Health Care Compliance policies.
• 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.
• 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 provide administrative and consulting support to the client's Clinical Research Review Committee, the client's Safety Review Committee, the client's Investigator Initiated Studies, and the client's Clinician Initiated Innovative Studies Program.
• The CCA will assist in conducting final audits of Trial Master File/eTMF in conjunction with Clinical Operations Associates to ensure that the client's Trial Master File and electronic Trial Master File is audit ready and complete in accordance with company SOPs, GCP, and FDA regulations.

Must Have:

1. 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
2. Background may include Compliance, Finance, Sales and Marketing, Medical Affairs, Legal, Pharmacovigilance, Regulatory, Auditing or Science Discipline.
3. Experience in working in clinical trials/studies and working knowledge of Good Clinical Practices (GCP), highly desirable.
4. Excellent interpersonal, oral communication, organizational, problem-solving, and analytical and time management skills.
5. Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines
6. Aptitude for learning new systems with minimal direction.
7. Must be detail-oriented with ability to efficiently fact-check and find errors.

Nice to Have:

1. Previous experience working in a corporate environment or pharmaceutical industry is desired
2. Experience in Health Care Compliance activities is a plus.
3. Proficient with Microsoft Office and ability to learn corporate systems - SharePoint, Totality, Ariba, ICD etc.
4. Experience in contracts, payment reconciliation and Fair Market Value Assessment.
5. Knowledge of Medical Device Regulations, FCPA and related regulations desirable, but not a must.
6. Prior experience as a Clinical Study Assistant or Clinical Research Associate.