University of Colorado Anschutz Medical Campus Department: Obstetrics and Gynecology, Division of Gynecologic Oncology

Job Title: Clinical Research Coordinator

00845224 – Requisition  39000

Job Summary:

The Clinical Research Coordinator (CRC) will work within the Division of Gynecologic Oncology in the Department of Obstetrics and Gynecology. The role will be to coordinate the daily activities required to conduct clinical research protocols, recruitment and enrollment of research participants, schedule study participant clinic visits, accurately record and enter data, process biospecimens, respond to data queries from study sponsors, and support physician investigators. The position may be utilized to support research at the main Anschutz Medical Campus. The CRC in this position will not be called on to make independent medical decisions at any time, but a solid fundamental knowledge of biological and medical sciences is necessary for this position. Additionally, appreciation of accepted methods of clinical research is highly desirable.

• Key Responsibilities:

• 25% - Study Subject Recruitment, Screening & Enrollment

• Obtaining study subject medical history and current medication information

• Reviewing research protocol Inclusion/Exclusion Criteria

• Confirming subject eligibility to participate in clinical trials

• Interviewing and educating prospective subjects via phone and in person

• Performing or ensuring the informed consent process has occurred, is properly documented, and consent forms are filed appropriately

• Gathering source documentation to support eligibility determination

• Scheduling and tracking prescreening, screening, and enrollment logs as required by Sponsor

• 30% - Study Coordination & Clinical Operations

• Scheduling subject participation in research clinical trials

• Coordinating availability of study space and clinical research support (physicians, nurse practitioners, laboratory, radiology, pharmacy)

• Collaborating with hospital staff to ensure protocol-required tests and procedures are performed and documented

• Serving as Primary Coordinator for clinical trials

• Working on multiple research studies simultaneously

• Serving as a liaison with Sponsors and study subjects for ongoing clinical research studies

• 25% - Data Management & Documentation

• Abstracting and recording research subject data onto protocol-specific Case Report Forms (CRFs) and into clinical trial databases

• Ensuring complete and accurate source documentation for each study subject record

• Reviewing study documents after each subject visit for completeness and accuracy

• Ensuring capture of all protocol-required data points

• Independently coordinating and managing data entry, data queries, and monitor visits

• Meeting with Monitors to respond to questions of data validity and correcting/revising data as appropriate

• 15% - Regulatory Compliance, Safety & Monitoring