Clinical Research Manager, Research Incubation Unit

Clinical Research Manager

The Clinical Research Manager is part of the Research Incubation Unit of the Office of Clinical Research. The Clinical Research Incubation Unit was established to enable growth of clinical research portfolios across the Biological Sciences Division as well as provide timely research staffing services to departments or units in need of short-term clinical research management services. The Clinical Research Manager manages a team of professional staff responsible for clinical research conduct, research participant management, data management, and regulatory. Key responsibilities of the Manager include recruiting, onboarding, and training of new clinical research staff; day-to-day management and supervision of clinical research staff; supporting study initiation and completion of key milestones throughout the life cycle of the trials; tracking and reporting on key metrics; communicating with investigators and department leaders; communicating with industry sponsors and internal stakeholders; and fulfilling service level agreement performance standards. This position will have primary accountability to the Director of Clinical Research Operations within the Office of Clinical Research.

Responsibilities include overseeing departmental clinical research portfolio across the lifecycle for each protocol from feasibility, startup, recruitment, day-to-day conduct, follow up through study close out; coordinating departmental clinical research staff and faculty meetings; overseeing the conduct of clinical research, regulatory compliance, and IRB filings for all projects in the departmental portfolio; and establishing departmental standard work and standard operating procedures.

Minimum qualifications include a college or university degree in a related field and 7+ years of work experience in a related job discipline. Preferred qualifications include a Master's Degree, experience with both industry sponsored FDA regulated clinical trial and investigator initiated clinical trial site management, regulatory support for FDA and IRB filings, and ACRP / SOCRA research certification.