Regulatory Analyst

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

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

Soft Skill/Attribute Requirements

Schedule/Shift