Scheduled Hours

40

Position Summary

Directly responsible for the supervision, oversight, training and education of research coordinators, and quality assurance monitoring of data in the Functional Research Groups. This position requires the ability to clinically assess protocols for budgetary and logistical issues associated with the coordination and implementation of clinical trials for institutional studies, cooperative group studies, and pharmaceutical industry-sponsored studies.

Job Description

Primary Duties & Responsibilities:

Leadership of the Functional Research Groups

• Manage clinical research staff, including clinical research coordinators (CRCs).  Key responsibilities include assigning clinical trials, managing study personnel across all trials, overseeing onboarding of new research staff, organize regular educational staff meetings, assist PIs with performance reviews, CRC credentialing, and facilitate staff promotions.
• Manage regulatory activities and lead start-up efforts for new clinical trials.  Key responsibilities include completing feasibility questionnaires, coordinating pre-study qualifying visits and site initiation visits (in conjunction with primary study coordinators), prepare/submit initial and continuing IRB documents. 
• In coordination with finance staff,  oversee finances of 50-75 clinical trials,  including analyzing/negotiating budgets, facilitate timely invoicing of sponsors, monitoring accounts receivables & individual study balances, and monitoring CRC/PI effort across trials. 
•  Develop and maintain generalizable (standard operating procedures (SOPs) and staff training materials.
• Serve as Division’s liaison with University’s research entities, including HRPO, CTRU, Research pharmacy, DOM research committees and BJH research groups, etc. Serve on appropriate research committees at the medical center and communicate their happenings to the PCCM Division. 

Other Functions

• Performs other duties as assigned.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Required Qualifications

Education:

Bachelor’s degree or combination of education and/or experience may substitute for minimum education.

Certifications:

No specific certification is required for this position.

Work Experience:

Clinical Research (1 Year)

Skills:

Not Applicable

Driver's License:

A driver's license is not required for this position.

More About This Job

Preferred Qualifications:

• It is preferred that candidates have Advance licensure (e.g. RN, RRT, RPh, Etc.) ,extensive clinical research experience (> 7 years), with all phases of clinical trials including patient-related activities, study start-up, IRB/regulatory, budget management, etc. 
• Experience with pharma/industry-sponsored is a prerequisite, while experience with federal/foundation awards and grant writing are also desirable.

Preferred Qualifications

Education:

No additional education beyond what is stated in the Required Qualifications section.

Certifications:

Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals (ACRP), Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SOCRA), Clinical Research Associate (CRA) - Association of Clinic