Clinical Research Supervisor
The Clinical Research Supervisor oversees daily supervision of Clinical Research staff. This position develops, negotiates, and monitors budgets for funded research projects. It also facilitates the implementation of clinical research projects and ensures quality and timely completion.
Essential Functions of the Role :
- Writes and assists in the development of proposals, grants, contracts, and budgets for the department.
- Assists in developing new protocols and materials from study sponsors. Provides input to Principal Investigators and management on clinical and research issues to establish financial and clinical feasibility.
- Assists various PIs, through delegated authority, in conducting clinical trials per federal, state, and institutional guidelines.
- Prepares initial project submissions, amendment notifications, SAE reports, continuing review reports, and other reports for the IRB. Reviews staff-prepared submissions to ensure they meet established standards.
- Oversees case report form completion by staff for all studies. Assists in coordinating audits by study sponsor monitors. Monitors assigned Clinical Research funds.
- Orientates, trains, supervises, and evaluates Clinical Research staff. Encourages growth through complex responsibilities and education programs. Coordinates project assignments for staff.
- Establishes and maintains good relations with the public, patients, and staff; promotes the department's research programs.
- Monitors communication with the IRB, Food and Drug Administration (FDA), and other applicable regulatory agencies.
Key Success Factors :
Research certification or other certifications per specialty area preferred.Basic Life Support (BLS) per department requirements.Proven written and oral communication skills.Proven computer skills, including Microsoft Office, Excel, and PowerPoint.Ability to manage time impressible projects in order to meet deadlines.Ability to establish and maintain effective working relationships.Excellent leadership skills.Qualifications :
Education - Bachelor's or 4 years of work experience above the minimum qualificationExperience - 2 Years of Experience