Clinical Research Coordinator

University of Colorado Anschutz Medical Campus

Department: Obstetrics and Gynecology, Division of Gynecologic Oncology

Job Title: Clinical Research Coordinator

Requisition Number:  – 39000

The Clinical Research Coordinator (CRC) will work within the Division of Gynecologic Oncology in the Department of Obstetrics and Gynecology. The role will 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. Appreciation of accepted methods of clinical research is highly desirable.

• 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
• Obtaining oncology grading levels for study product toxicities
• Assessing clinical significance of laboratory and test results and relatedness of adverse reactions per protocol
• Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) to appropriate parties (PI, Sponsor, FDA, DSMC, Regulatory Affairs)
• Assuring compliance with all protocol requirements and regulatory standards
• Assisting with Sponsor, Data Safety Monitoring, and FDA audits and responses
• Assisting with regulatory submissions
• Ensuring the most current and approved informed consent documents are used and properly filed
• 5% - Administrative, Financial & Professional Development
• Assisting Team Manager and/or Financial Team with billing processing and billing-related questions
• Maintenance of study-specific certifications, COMIRB training, computer training, and other hospital-required training

Hybrid – this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings.

Medical research is the engine that drives CU Anschutz Gynecologic Oncology as we conduct more clinical trials and research than any other gynecologic oncology practice in the state of Colorado. Our research faculty focus on clinical, translational, and basic science approaches to finding novel treatments for gynecological cancers. Clinical…