Clinical Trials Regulatory Lab Manager

Responsibilities

• Prepare regulatory submissions (such as IRB and IND/IDE) and applications and annual reports.
• Complete all related regulatory documents and maintain correspondence and telephone contacts with regulatory agencies.
• Submit annual reports and updates as required.
• Serve as expert liaison in specialized compliance or scientific area between the investigators and regulatory agencies.
• Provide regulatory support, guidance, and information to principal investigators and research staff.
• May consult on protocol development.
• Develop, deliver and manage tools to facilitate education and training, prepare written materials to communicate with research community including presentations, one-on-one training and orientation sessions.
• Oversee and maintain regulatory documentation, safety reporting procedures and audit safety reports to ensure they are appropriately handled.
• Evaluate and analyze the impact on new regulations and determine how to implement within unit.
• Apply knowledge of international, federal, state and local regulations as well as university policies to ensure optimal compliance.
• Serve as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizations or committees.
• May manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams.
• May hire, orient, and provide ongoing training and direct supervision to regulatory staff.
• Assign work tasks, provide daily supervision of these tasks; provide verbal and written evaluation of work performance.
• May contribute to establishing and developing Standard Operating Procedures for the conduct of clinical research.
• Ensure SOPs are compliant with international, federal, state, and local regulations, and consistent with the objectives of the clinical research operation.

Qualifications

• Experience with working with human subjects in clinical trials/clinical research for at least 5-6 years including oversight of recruitment, enrollment, study close out, sponsor correspondence, and PI support.
• Experience with University IRB.
• Experience with NIH/NIMH regulatory processes.
• Strong communication skills both written and verbal.
• Understanding of the Clinical Trial process from beginning to end including experience managing critical NIH interactions, trial site management, and working with commercial and institutional review boards (IRB).
• Experience working with the National Institutes of Health (NIH) and/or industry/external Sponsors.
• Demonstrated problem-solving abilities in managing clinical sites and demonstrated tactfulness and diplomacy in communicating with investigators, participants, and study coordinators.