Clinical Research Regulatory Coordinator
Posting Description: This position interprets, coordinates, and executes adherence with all policies and procedures as they pertain to the conduct of clinical research within the Division of Gastroenterology & Hepatology of the Department of Medicine. Working under the direction and guidance of the Division's Director of Clinical Research, the employee has authority over related regulatory affairs, research funds and resources of the Division. The employee represents the Division within the Department and the School of Medicine, the Health Sciences Center, and the University of Colorado, providing essential communication and networking for the effective functioning of these entities.
Duties and Responsibilities Specific duties and responsibilities of the Clinical Research Regulatory Coordinator employee may include, but are not limited to, the following:
Regulatory Management Responsible for the site regulatory compliance involving 1) the Colorado Multiple Institutional Review Board (COMIRB) 2) Clinical Translational Research Center (CTRC) 3) Clinical Trials Office (CTO) 4) Hospital Research Review Committee (HRRC) 4) National Institutes of Health (NIH) 3) Western Institutional Review Board 5) and various industry sponsors or other institutional entities as required by the research projects.
Financial Management Utilize standard University and departmental systems for accounting, data processing and other computer systems as necessary for financial management and statistical reporting as related to the Division's clinical research regulatory issues. Work with other Division personnel to assist research faculty and fellows with budget and routing paperwork for processing grants submissions.
Planning Participates in the planning activities of the Division's research administrative team, including long range and short range planning. Works with the Director of Clinical Research, the Division Administrator, and the Division Head, as well as other faculty members as needed or requested to analyze and report existing and/or new research projects to interested parties.
Minimum Qualifications: A bachelor's degree from an accredited college or university is required with a preference major in business/public/health administration, or closely related field.
Required Competencies/Knowledge, Skills, and Abilities: Excellent knowledge of COMIRB and WIRB regulations. Strong management skills to include comprehensive understanding of academic medical institution structure and operational standards. Ability to prepare and present analytical assessments and reports, and to communicate professionally and effectively. Excellence in establishing work priorities, providing follow through, and meeting established deadlines. Ability to successfully plan, organize, implement, and coordinate research regulatory activities in a diverse and complicated system.
Desired Qualifications: Extensive experience with clinical research. Three years of responsible administrative experience, preferably in research regulatory administration of management. Preference would be experience in an academic medical and/or setting. Experience with the administration processes related to budgets and grant submissions.
Campus: Anschutz Medical Campus