Research Compliance Specialist
Actalent
- Atlanta, GA
- Permanent
- Full-time
- Ensures that research is being conducted in compliance with the study protocols, institutional policy and GCP.
- Reviews protocols and supports development of the study calendar within the OnCore system.
- Reviews the accuracy, completeness and timeliness of study related records, case report forms and other documents.
- Reviews study related processes relative to applicable regulatory requirements, including the FDA's GCP regulations and departmental guidelines.
- Reviews drug or device accountability, tracking records, and clinical research pharmacy processes. Verifies that appropriate storage, supply, usage, instruction, documentation and disposition processes are in place and followed.
- Utilizes appropriate monitoring check-lists and report templates to record and report monitoring findings in writing, and communicates such findings to the appropriate parties (Central Research Department management, the principal investigator, and designated members of the regulatory and clinical trials staff.)
- 3+ years of experience in clinical research setting
- 1 year monitoring or administering complex clinical trials
- Sound knowledge of ICH, FDA, GCP, human subject protection, and IRB regulations and processes
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people