Overview
Key Duties & Responsibilities
- Audit Investigator Initiated Trials (IIT), Cooperative trials and pharmaceutical sponsored trials.
- Conduct internal quality assurance audits of regulatory files.
- Assist in the design and implementation of quality initiatives ensuring effective and efficient clinical processes.
- Verify compliance with protocols, Standard Operating Procedures (SOPs), FDA, ICH and GCP regulations.
- Maintains QA data files.
- Prepares accurate audit reports, makes recommendations for corrective actions with input/review from Director Quality Management.
- Assists with follow-up on sponsor and internal audit queries. Including assisting with the writing of Corrective and Preventive Actions (CAPA) when applicable.
- Escalate and present major findings to the Director of Quality Management.
- Identify needed training programs for clinical research staff based upon quality assurance reviews and reports. Including but not limited to ALCOA, source documentation completion, and overall QA process training.
- Responsible for Quality Management and preparation of study-related material for FDA, EMA, and Sponsor audits with assistance as necessary.
- When applicable participate in pre-study meetings as QA representative Evaluate and present Quality Assurance findings/metrics to appropriate staff members and managers.
- Performs other duties as assigned.
Selling Points
- Growing department that will start bringing in new trials.
- Small team in a big hospital system so really get to know teammates.
3-5 Must Have Skills/Qualifications
- 3 Years of CRC/Regulatory Experience in complex studies
- Candidates must have experience in therapeutic areas like Rheumo/Neuro/Oncology/auto immune (No candidates with Derm/ENT/Observational therapeutic areas unless its coupled with the others.
- Must be willing to be onsite 5 days a week.
Nice to Have Skills
- Experience in Regulatory with a Sponsor/CRO
Soft Skill/Attribute Requirements
- Strong Attention to detail
Schedule/Shift
