University of Colorado Anschutz Medical Campus

Department: Medicine – Division of Gastroenterology and Hepatology

Job Title: Clinical Research SURVENT Project Coordinator

Position #: 00783762 – Requisition #: 40130

Job Summary:

As an important member of the research team, the Clinical Research SURVENT Project Coordinator works with industry-sponsored, co-operative group and/or investigator-initiated clinical trials in accordance with the trial protocols, FDA Regulations, and ICH/GCP Guidelines. This position is accountable for meeting study-specific goals and timelines, while also performing and assisting with clinical tasks related to study-specific tests, procedures, and treatments as assigned based on appropriate licensure and/or completion of competency documentation and team needs. The Project Coordinator communicates appropriately and effectively with study subjects, investigators, and other team members and has outstanding customer service skills and accepts responsibility in maintaining relationships that are equally respectful to all. This position is responsible for the implementation and coordination of clinical trials and investigator-initiated studies conducted by Dr. Sachin Wani and colleagues at the University of Colorado.

Key Responsibilities:

• Assist with and oversee the day-to-day operations of clinical trials and studies.

• Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines.

• Serve as the primary operational contact for participating sites involved in the SURVENT study.

• Provide training and onboarding for site investigators and research staff on study protocols, procedures, and study documentation.

• Provide guidance and respond to questions regarding biospecimen collection, processing, storage, and shipment requirements.

• Collect information to determine feasibility, recruitment and retention strategies. Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention.

• Serve as a resource and participate in study initiation and close out