The full time Night Clinical Research Coordinator provides regulatory, study coordination, and data collection support for the Clinical Research Support Team (CReST). CReST is part of Colorado Clinical and Translational Sciences Institute. CReST provides support to clinical investigators for all activities related to the successful conduct of clinical research, from study start-up through close out. After an initial period of onboarding and training that will take place during daytime business hours, this position will work from 10:00pm to 9:00 am Mon-Thur to support research studies that need overnight coordination services.
Examples of Work Performed:
Adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), and other pertinent regulatory agencies.
Assures protocol compliance and completes necessary records.
Relays timely information to PI’s, study staff, and CReST Leadership (e.g. addition of investigators, amendments, serious adverse events, consent form changes, monitoring visits, correspondence, continuing review and study termination reports) verbally and in writing.
Reviews protocol inclusion/exclusion criteria, and confirms study eligibility.
Conducts the informed consent process, and ensures that it is properly documented.
Recruits prospective participants and conducts data collection visits for multiple clinical studies.
Biological specimen processing
Familiarizes potential participants with the details of the study through phone contacts and in-person interviews.
Accurately transfers source documentation into Case Report Form (CRF).
Reviews records after each visit for completeness and accuracy.
Maintains participant research files
Works with manager to coordinate scheduling of participant and monitoring visits.
Other duties as assigned by manager
Bachelor of Science or equivalent degree
Previous clinical research experience
Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint)
Superior communication and organizational skills
Must be able to work independently following training
Internal Number: 15060
About University of Colorado Denver
The University of Colorado Anschutz Medical Campus ranks among the top institutions nationally in clinical care, education and research. Its 230-acre campus, designed to enhance collaboration and interprofessional education, hosts the College of Nursing; the Schools of Dental Medicine, Medicine, Pharmacy, and Public Health; the Graduate School; a Health Sciences Library; and two hospitals. Strategically located contiguous to the campus are a biosciences research park and the soon-to-be-completed Veterans Hospital. CU Anschutz offers two undergraduate degrees, 35 graduate degrees, and five first-professional programs. More than 4,000 students learn alongside faculty members who also make meaningful medical discoveries and provide expert clinical care through 1.5 million patient-visits annually. A hub for research and innovation, CU Anschutz receives over $400 million in research awards each year and has filed 1,300 patent applications and formed 53 new companies since 2002.