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
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.
- 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.
- 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 requirements.
- Reviews payroll on industry sponsored projects is accurate with PIs.
- Performs final reviews for study closeouts.
- Develops and presents educational content to department research faculty, staff, and professional research assistants at quarterly research meetings, faculty meetings, and other relevant meetings as necessary.
- Develops original content for department research edition newsletter, including advising research personnel on changing regulations and policies/procedures.
- Assists the research services manager with developing general research policies and procedures relating to clinical research and is independently responsible for development and maintenance of department SOPs relating to regulatory policies and procedures.
- Cross-trains with the other members of the team and provides service coverage when needed.
- Identifies and participates in training opportunity to enhance knowledge in all areas of responsibilities.
- Other duties as assigned.
The salary for this position begins at $54,428 and is commensurate with skills and experience. This position is not eligible for overtime compensation.Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
Total Compensation Calculator: http://www.cu.edu/node/153125Diversity and Equity:
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at [email protected] The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.The University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
- A bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.
- Experience working in an academic research environment.
- Two (2) years of experience with clinical research coordination.
- Two or more years of professional medical, clinical and/or experience coordinating clinical research.
- Experience working with academic Institutional Review Board or the conduct of FDA-regulated clinical trials.
- Experience with Oncore, InfoEd, CU Data, Marketplace, etc.
- Experience communicating with Industry Sponsors.
- Experience with clinical research budgeting.
- Certified Clinical Research Professional (CCRP).
- Demonstrated ability to work effectively with a diverse population of faculty, staff and students.
- Excellent knowledge regarding clinical research regulations and principals of ethical conduct.
- Knowledge, experience, and ability to manage complex information and computer systems.
- Effective communication/presentation skills and a proven track record of forming collaborative and effective working relationships with physicians and administrative leaders.
- Demonstrated commitment and leadership ability to advance diversity and inclusion.
Job Category: Research Services
Primary Location: Aurora
Posting Date: Nov 16, 2020
Unposting Date: Ongoing