Manager - Clinical Trials Office
- Location: Baton Rouge, LA
- Posted: May 22, 2019
The Manager, Clinical Trials Office is responsible for the day-to-day management, operation and accountability for the Clinical Trials Office. Duties include develop and implement a program of performance improvement to insure the performance of the Clinical Trials Office. Evaluates the effectiveness of departmental operating procedures, and recommends procedural and organizational changes. Ensures that clinical trials are implemented in accordance with standard practice. Effectively addresses concerns regarding Clinical Trials Office services, and in working with staff to resolve the concerns. Promotes continuous quality improvement within department through staff education, monitoring and ongoing improvement projects. Develops and implements financial and operational processes to ensure Clinical Trials Office compliance with federal regulations and best research practices. Develops and maintains clinical research budgets, billing, and accounts receivables. Reviews and revises clinical trial agreements. Negotiates study budgets with sponsors and oversees researach feasibility assessments and billing compliance.
Minimum of 5 years experience in healthcare research and clinical trials administration.
Bachelors degree, Masters preferred.
SPECIAL SKILL, LICENSE AND KNOWLEDGE REQUIREMENTS
Detailed knowledge of human subject protection and research compliance regulations, including PHS, FDA, HIPAA and OHRPP required