Clinical Research Coordinator

DescriptionUniversity of Colorado | CU Anschutz Medical Campus
School of Medicine, Department of Obstetrics and Gynecology
Research Services Senior Pro (Clinical Research Coordinator)
Position #726938– Requisition #19580* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.The Department of Obstetrics and Gynecology has an opening for a full-time University Staff (unclassified) Clinical Research Coordinator position.The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here. Nature of Work:
As a vital team member of the Administrative Research Core, the Clinical Research Coordinator is responsible for assisting the Ob-Gyn faculty with planning, organizing, and managing operational activities related to clinical research protocols, including Institutional Review Board (IRB) submissions and the Office of Grants and Contracts (OGC) routing process. This position will be responsible for ensuring departmental compliance with diverse federal, state, and university regulations, policies, and procedures governing Ob-Gyn clinical research efforts. Supervision Received: This position reports to the Research Services Manager.Supervision Exercised: This position will include the management of clinical research projects and will have authority to make business decisions as they relate to the administration of these functions. The position will not supervise other employees. Examples of Work Performed:Regulatory:

• Responsible for the overall management of regulatory submissions for Ob-Gyn investigators, as well as regulatory compliance of research activities within the department.


• Independently advises on and generates complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado, including:
  
  
  • The Colorado Multiple Institutional Review Board (COMIRB)
  
  
  • Scientific Advisory & Review Committee (SARC)
  
  
  • Protocol Review and Monitoring System (PRMS)
  
  
  • Human Subjects Research Portal (HSR)
  
  
  • Clinical and Translational Research Centers (CTRC) and Clinical Trials Office (CTO)
  
  
  • UCH Research Support Services (RSS)
  
  
  • Denver Health Sponsored Research Office (SPARO)
  
  
  • National Institutes of Health (NIH)
  
  
  • Children’s Research Institute (RI)
  
  
  • US Food and Drug Administration (FDA)
  
  
  • Various industry sponsors or other institutional entities as required by the research projects
  
  
  
  


• Develops (or provides oversight of the development of) clear and accurate subject informed consent documents and HIPAA authorization documents for investigators.


• Routes DUAs, MTAs, BAAs, and other clinical agreements for full execution and monitors progress following up as needed.


• Serves as OnCore trainer and "super user" for Ob-Gyn.


• Maintains a comprehensive record keeping system of clinical research data and reports metrics of productivity on a monthly basis to Department research leadership.


• Maintains regulatory document e-files for each clinical research protocol.


• Conducts quality assurance reviews of research participant and study files and advises on best practices relating to clinical research.


• Serves as regulatory liaison between Ob-Gyn researchers and University committees involved in the review and approval of research projects.

Industry Sponsored Pre-Award:

• Develops clinical budgets for industry-sponsored clinical trials/studies.


• Reviews and interprets relevant federal, state, local, and university rules, regulations, and guidelines and communicates these to Ob-Gyn investigators and research assistants.


• Routes to OGC for budget review and coordinates HSR portal submission.


• Oversees contract reviews to full execution.


• Communicates with sponsors, investigators, and study teams for budget negotiations.

Industry Sponsored Post-Award:

• Collaborates with PI and study team to prepare and submit invoices.


• Updates and distributes financial projections to PIs on a monthly basis.


• Processes JEs and PETs as needed for account management and project clean-up.


• Tracks invoices sent and payments received according to the project invoicing