Clinical Research Coordinator II

Job Description

Job Description

Overview

The Clinical Research Coordinator (CRC) is a specialized, independent research professional who ensures oversight and compliance of both system-wide and local SHC clinical research activities. Reporting to the Clinical Research Program Manager or (local Hospital Administrator / Clinic Director) and Research Programs Office at SHC International Headquarters, the CRC provides support in accordance with SHC’s policies and procedures, SHC’s hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines, when applicable. The CRC works closely with the Chief of Staff, SHC scientific and medical staff and other research personnel to ethically recruit and consent SHC’s vulnerable pediatric subjects and to appropriately collect and safeguard data. Overall, the CRC is the site’s primary liaison among research participants, 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. Shriners Salt Lake City has an opportunity for a Clinical Research Coordinator II to join our team!

Responsibilities

• Maintains a contemporary knowledge of clinical research regulatory requirements. Has a working knowledge of the complex clinical research process, from protocol development to implementation
• Responsible for tracking all aspects of projects including all study, investigator and Institutional Review Board (IRB) information, patient recruitment activity, and financial management
• Works closely with investigators, research leadership, study sponsor and regulatory agencies to conduct and report the results of clinical research
• Coordinates the collection, statistical analysis and dissemination of data results throughout a clinical study. Evaluates protocols under consideration for feasibility, including the process for data collection, entry, storage and reporting
• Safeguards all participants involved in a research study supported and approved by Shriners Children's
• Facilitates the local site’s research programs and projects through collaborative, timely communications and teamwork
• Provides expertise consultation and mentorship to site staff, residents, students, and volunteers with respect to research processes, Good Clinical Practices, and regulations governing clinical research. Interacts with other departments in a professional and timely manner to facilitate research coordination.

Note: This is not an all-inclusive list of this job's responsibilities. The incumbent may be required to perform other related duties and participate in special projects as assigned.

Qualifications

Required

• Without a Bachelor's degree, 5 or more years of specific job-related experience in the administration of clinical research
• 3 or more years Clinical research experience, e.g. experience with site management, study management, IRBs, and federal regulations regarding clinical research compliance

Preferred

• Bachelor's Clinical Research, science or other healthcare related field
• Master's Clinical Research, science or other healthcare related field
• Experience in the coordination of intergroup or multi-site clinical studies
• CCRP or CCRC certification