Clinical Research Coordinator

University of Colorado Anschutz Medical Campus

Department: Obstetrics and Gynecology, Division of Gynecologic Oncology

Requisition:

The Clinical Research Coordinator (CRC) works within the Division of Gynecologic Oncology to coordinate the daily activities required to conduct clinical research protocols, including recruitment and enrollment of research participants, scheduling study visits, accurately recording and entering data, processing biospecimens, responding to data queries from study sponsors, and supporting physician investigators. The CRC will not make independent medical decisions but must possess a solid understanding of biological and medical sciences and an appreciation of accepted methods of clinical research.

• 25% - Study Subject Recruitment, Screening & Enrollment
  • Obtain study subject medical history and current medication information
  • Review research protocol inclusion/exclusion criteria
  • Confirm subject eligibility to participate in clinical trials
  • Interview and educate prospective subjects via phone and in person
  • Ensure the informed consent process has occurred, is properly documented, and consent forms are filed appropriately
  • Gather source documentation to support eligibility determination
  • Schedule and track prescreening, screening, and enrollment logs as required by Sponsor
• 30% - Study Coordination & Clinical Operations
  • Schedule subject participation in research clinical trials
  • Coordinate availability of study space and clinical research support (physicians, nurse practitioners, laboratory, radiology, pharmacy)
  • Collaborate with hospital staff to ensure protocol‑required tests and procedures are performed and documented
  • Serve as Primary Coordinator for clinical trials
  • Work on multiple research studies simultaneously
  • Serve as a liaison with Sponsors and study subjects for ongoing clinical research studies
• 25% - Data Management & Documentation
  • Abstract and record research subject data onto protocol‑specific Case Report Forms (CRFs) and into clinical trial databases
  • Ensure complete and accurate source documentation for each study subject record
  • Review study documents after each subject visit for completeness and accuracy
  • Ensure capture of all protocol‑required data points
  • Independently coordinate and manage data entry, data queries, and monitor visits
  • Meet with Monitors to respond to questions of data validity and correct/revise data as appropriate
• 15% - Regulatory Compliance, Safety & Monitoring
  • Obtain oncology grading levels for study product toxicities
  • Assess clinical significance of laboratory and test results and relatedness of adverse reactions per protocol
  • Report adverse events (AEs) and serious adverse events (SAEs) to appropriate parties (PI, Sponsor, FDA, DSMC, Regulatory Affairs)
  • Assure compliance with all protocol requirements and regulatory standards
  • Assist with Sponsor, Data Safety Monitoring, and FDA audits and responses
  • Assist with regulatory submissions
  • Ensure the most current and approved informed consent documents are used and properly filed
• 5% - Administrative, Financial & Professional Development
  • Assist Team Manager and/or Financial Team with billing processing and billing‑related questions
  • Maintain study‑specific certifications, COMIRB training, computer training, and other hospital‑required training

Hybrid – eligible for 3 days per week on campus and as needed for in‑person meetings.

Medical research drives CU Anschutz Gynecologic Oncology, making us the most active gynecologic oncology practice in Colorado. Our faculty focus on clinical, translational, and basic science approaches to discover novel treatments for gynecological cancers. Our research extends to cervical, ovarian, endometrial, vulvar, peritoneal, and fallopian tube cancers, as well as lifestyle factors such as diet and exercise.

We offer excellent benefits including generous holiday, vacation, and sick leave, along with comprehensive medical and dental plans, additional insurance, a 401(a) retirement plan with 10% employer contribution, paid time off accruals, and tuition assistance.

• Medical:
  Multiple…