Clinical Research Manager

Clinical Research Manager

Required upon hire : ACRP or SOCRA certification, or other Clinical Research Certification

Education :

Bachelor's Degree Required

Master's Degree Preferred

Experience :

• 7 years of Clinical research experience REQUIRED
• 5 years in management or supervision of clinical trials REQUIRED.
• 5 years Experience in clinical research finance REQUIRED
• Experience in managing data collection, reporting, outcomes, quality improvement, standards / pathways REQUIRED
• Experience in meeting FDA (GCP, ICH guidelines), as well as other Federal, State and Local regulations surrounding human research REQUIRED.
• Experience with working with Pharmaceutical and FDA agency representatives REQUIRED.

Summary

Under the supervision of the Director, the Manager of Clinical Research is responsible for assuring the strategic vision, directions and operations of the clinical research finance department are implemented and adhered to by all staff. Responsible for oversight of the day to day operations of the clinical research finance team. Responsibilities include compliance with regulations and assure good communication between the various ministries, stakeholders and leadership. Assists in developing, implementing and maintaining policies and procedures. Assists in providing on-going formal and informal training for research staff.

Responsible for overseeing the development of research contracting and budgeting standards. Directs the negotiation of contracts for clinical trials and determination of internal costs and development of internal budget for negotiations of sponsored and investigator initiated clinical trials in compliance with applicable state and federal laws and regulations, especially Medicare and Stark Law. Lead the development and implementation of study builds in the clinical trial management system (CTMS).

Skills Needed :