The Supervisor of Clinical Research serves as clinical and administrative leader that communicates, organizes, prioritizes, leads, facilitates, and problem-solves under the direction of the Director of Clinical Research to enhance access to clinical trials. The incumbent has expert experience in the discipline of clinical research assignment and supervises a specified team in the Renown Research Office as delegated by the Director of Clinical Research. The incumbent is responsible, in collaboration with the Renown Research Office leadership for oversight of all aspects of clinical trials within their assigned specialty area(s) and management of the specialty area(s) to increase the clinical trial portfolio and increase enrollment. The Supervisor of Clinical Research is also responsible for conducting internal audits of clinical trials within the study portfolios of their direct reports, measuring study performance metrics, and implementing action plans, and managing the implementation of assigned departmental initiatives. Additionally, the position requires preceptorship and mentoring of clinical research coordinators, associates, and assistants, and is a resource for all department staff.

The incumbent is challenged to provide oversight of the clinical research team and research protocols with an extremely high degree of accuracy, adheres to project timelines, ensures proper quality assurance measures are taken and complies with all regulatory requirements. The Supervisor must stay current on the understanding of all regulations specific to human research subject protections and informed consent. The incumbent must be highly organized, demonstrate technological proficiency, and must also have good interpersonal skills to communicate with research staff, physicians, physician staff, study sponsors, and research participants.

This position prepares, submits, and monitors documentation of research program activities while assuring compliance with regulations and protocols. Performs assigned administrative, clinical, and technical duties as directed. Duties include but are not limited to participant and study management, facilitating research team training, implementation and maintenance of department projects, creation of study profiles in all internal research systems including summary and billing information, performing staff evaluations, and supporting staff career development as delegated by the Director of Clinical Research. Completes other work as requested.

This position is challenged to manage a large volume of items while maintaining a high degree of accuracy and efficiency with significant attention to detail. Working knowledge of all regulatory requirements governing IRB guidelines. The position requires strong decision-making, independent judgment, and analytical skills in order to apply federal and state regulations to a variety of situations.

This position provides patient care.

The foregoing description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills and efforts or work conditions associated with the job. It is intended to be an accurate reflection of the general nature and level of the job.

Name

Description

Education:

Must have working- level knowledge of the English language, including reading, writing, and speaking English. Bachelor of Science in health sciences or bachelor’s degree with 2-year experience in health-related field strongly preferred. 4 years of clinical research experience may substitute for bachelor’s degree.

Experience:

2 years of experience as Clinical Research Coordinator or equivalent position. Previous experience caring for patients on a research protocol. Demonstrated experience in prioritizing and organizing work preferred.

License(s):

Ability to obtain Office Laboratory Assistant credentialing following job-specific training within 6 months of hire.

Certification(s):

AHA BLS certification is required within 90 days of hire.

Human Subject Protection Certificate and GCP Training Certificate required within 90 days or hire.

IATA certification required within 90 days or hire.

CCRP or CCRC preferred within 36 months of hire.

Computer / Typing:

Must be proficient in Microsoft Office Suite, including Outlook, PowerPoint, Excel, Teams, and Word and have the ability to use the computer for online learning requirements for job-specific competencies, access online forms and policies, complete online benefits enrollment, etc.