General Responsibilities
• To prepare and submit multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
• To prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).
• To lead the implementation of study-specific regulatory processes of a moderate to complex nature.
• To conduct internal quality assurance audits of regulatory files as well as programs, reports, and teams working within clinical trial operations.
• To design and implement quality initiatives ensuring effective and efficient clinical processes.
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 the Director of 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 .
Qualifications
Bachelor's degree in a related field and five (5) years of related experience required. Work experience may NOT substitute for education requirement. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred.
Preferences
• Knowledge of ICH-GCP guidelines.
• Accuracy, thoroughness, and attention to detail are imperative.
• Skilled in maintaining/reviewing records.
• Skilled in developing and maintaining effective working relationships with staff.
• Ability to work independently as well as within a team.
• Ability to communicate effectively with peers, physicians, and management both orally and in written form.
• Must be self-directed/self-motivated.
• Skill in time management and executing workload with minimal supervision.
