Clinical Research Coordinator
* Applications are accepted electronically ONLY at *
University of Colorado Denver l Anschutz Medical Campus
Colorado Clinical and Translational Sciences Institute
Clinical Research Coordinator
Position #732286 - Requisition 08878
Job Summary:This full-time, University Staff (non-classified) Clinical Research Coordinator provides regulatory, study coordination, and data collection support for the Clinical Research Support Team (CReST). CReST is a part of Colorado Center of Translational Science Institute that provides support to clinical investigators for all activities related to the successful conduct of clinical research, from study start up through close out. This is the cornerstone for translating basic science knowledge into clinically useful treatment for patients. Examples of Work Performed:
* Assures 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. * 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). * Reviews protocol inclusion/exclusion criteria, and confirms study eligibility. * Conducts the informed consent process, and insures that it is properly documented.
* Recruits prospective participants and conducts data collection visits for multiple clinical studies. Familiarizes potential participants with the details of the study through phone contacts and in-personal interviews. * Assures protocol compliance, completes necessary records. Accurately transfers source documentation into Case Report Form (CRF) within 7 working days. Reviews records after each visit for completeness and accuracy. Maintains participant. research files * Coordinates scheduling of participant and monitoring visits. * Recognizes adverse events and serious events and promptly notifies appropriate parties. * Assists with processing bills and/or answering billing questions related to procedures performed for participants enrolled in clinical studies * Participates in Data Safety Monitoring Committee (DSMC), FDA, and other audits. * Other duties as assigned by manager * May perform the following procedures (with training): A) blood pressure, pulse, height, weight, and temperature measurements, b) specimen processing and shipping, c) pulse oximetry.
Salary and Benefits:
The hiring salary range for this position is $41,374 - $48,000 and is negotiable and commensurate with skills and experience.
The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at .
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.
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.
- Must be willing and able to lift up to 20 pounds on occasion.
- Must be willing and able to kneel, crouch, and stoop on occasion.
- 1 or more years' experience supporting cardiology clinical trials (interventional cardiology & imaging research, electrophysiology, and heart failure).
- Experience with NIH-sponsored and industry clinical research studies, including multi-center clinical trials.
- Experience working with physicians and nurses in clinical research.
- Knowledge of Good Clinical Practice (GCP)/ICH guidelines in clinical research.
- Excellent interpersonal communication, organizational skills, and ability to problem solve and multi-task.
- Ability to work both independently upon training and part of a multi-disciplinary team.
- Good command of the English language, both written and verbal.
- Ability to operationalize written protocols.
- Ability to work under pressure in a deadline oriented environment.