Clinical Research Coordinator 2

The Division of Gastroenterology and Hepatology has a long tradition of major contributions in basic research, a new commitment to clinical and outcomes research, a track record of training fellows for academic careers, and a longitudinal commitment to providing care for patients with complex gastrointestinal and liver diseases.

The Clinical Research Coordinator 2 (CRC2) will provide support for clinical research efforts in the Division of Gastroenterology and Hepatology. In this role, the CRC2 will independently manage 4-6 gastroenterology complex clinical drug studies to test novel therapies in Inflammatory Bowel Diseases and chronic liver disease. Responsibilities will also include overseeing investigator-initiated studies. These studies will focus on testing novel therapies in human subjects to treat inflammatory Bowel disease like Crohn’s and Ulcerative colitis, viral liver disease, metabolic dysfunction associated with steatotic liver disease, alcohol-associated liver disease, and cirrhosis, and will include Phase 1, Phase 2, and Phase 3 studies. The CRC2 will independently manage the studies from start-up through close-out and conduct FDA audits if applicable.

Core Duties:

• Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
• Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
• Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.
• Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
• Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions.
• Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
• Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
• Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.
• Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance.
• Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.
   

Minimum Education and Experience

Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

Knowledge, Skills and Abilities:

• Strong interpersonal skills.
• Proficiency in Microsoft Office and database applications.
• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
• Knowledge of medical terminology.
   

Certificates and Licenses Required

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.