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Clinical Research Program Manager

4 months ago

Lexington, United States Shriners Childrens Hospital Full time

Company Overview

Shriners Children's is a family that respects, supports, and values each other. We are engaged in providing excellence in patient care, embracing multi-disciplinary education, and research with global impact. We foster a learning environment that values evidenced based practice, experience, innovation, and critical thinking. Our compassion, integrity, accountability, and resilience defines us as leaders in pediatric specialty care for our children and their families.

Job Overview

Shriners Children's, the premier pediatric burn, orthopaedic, spinal cord injury, cleft lip and palate, and pediatric subspecialties medical center, has an opportunity for a Clinical Research Program Manager to join our team.

Responsibilities

The Clinical Research Program Manager (CRPM) is a specialized, independent research professional who is responsible for operational management, overseeing all local SC's clinical research activities. Reporting to the Hospital Administrator and Research Programs Office at SC's International Headquarters, the CRPM provides support and leadership in accordance with SC's policies and procedures, SC's hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines, when applicable. The CRPM works closely with the Chief of Staff, SC's scientific and medical staff and other research personnel to ethically recruit and consent SC's vulnerable pediatric subjects and to appropriately collect and safeguard data. Overall, the CRPM is the site's primary liaison among research participants, local study staff, the local investigator(s) and study sponsor(s). This position's main responsibilities are to help ensure proper study conduct, subject safety, and the quality of data and data safeguards. This position will provide management for the day-to-day operations of the clinical research program; ensure competent and standardized staff practices, and coordinate strategies to enhance interdisciplinary communication and collaboration.

Qualifications

Current full Covid-19 vaccination status requiredBachelor's Clinical Research, science or other healthcare related field PreferredMaster's Clinical Research, science or other healthcare related field Preferred

Without a Bachelor's degree, 5 or more years of specific job-related experience in the administration of clinical research is required.

3 or more years Clinical research experience, e.g. experience with site management, study management, IRBs, and federal regulations regarding clinical research compliance - required.

Experience in the coordination of intergroup or multi-site clinical studies - preferred.

CCRP or CCRC certification preferred.