The Lead Clinical Research Coordinator provides unit leadership under the direction of the research area’s Supervisor and Manager of Clinical Research. The incumbent has expert experience in the discipline of clinical research assignment and provides leadership over the specified coordinator pool in the Renown Research Office. This includes participation in study start-up, patient recruitment and enrollment, data collection, source documentation, quality assurance, regulatory submissions, and protocol dissemination to health care professionals, patients and family members, and study close-out for all assigned research studies. Further, this position requires the incumbent to function as an integral part of the research and care teams, working with colleagues to meet deadlines and the needs of patients, the specialty area, and the Research Office. Additionally, the position requires preceptorship and mentoring of clinical research coordinators and associates and is a resource for all department research staff.

The incumbent is challenged to provide oversight of the clinical research coordinator and research associate pool 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 Lead must stay current on the understanding of all regulations specific to human research subject protections and informed consent. While the incumbent must be highly organized and tolerant of isolation, this person 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 scheduling and consenting participants, coordinator pool training, data entry, assist research area Supervisor and Manager of Clinical Research on staff evaluations and staff career development. Completes other work as requested.

Serves as a Renown Health Lead Clinical Research Coordinator in the Renown Research Office.

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):

Valid Clinical Research Certification, SoCRA or ACRP Certification required to be obtained within 36 months of hire.

The following CITI certifications are required: Group 2. Biomedical Research Investigators and Key Personnel; Good Clinical Practice; Shipping and Transport of Regulated Biological Materials.

Computer / Typing:

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