Research Services Senior Professional

Research Services Senior Professional

Position:
Research Services Senior Professional, Department of Obstetrics & Gynecology, Division of Gynecologic Oncology, University of Colorado Anschutz Medical Campus.

Senior clinical science professional who independently coordinates and manages clinical research studies involving human participants, ensuring protocol compliance and participant support.

• Coordinate and manage clinical trial enrollment activities, including participant screening, eligibility verification, informed consent, education, and scheduling of study visits and required clinical services.
• Serve as the primary point of contact for assigned clinical trials, collaborating with physicians, nurses, sponsors, and hospital departments to ensure protocol compliance and participant support.
• Oversee study operations, including collection, processing, documentation, and shipment of research specimens, as well as development of study–specific tools and source documents.
• Maintain accurate and complete research records by collecting, reviewing, and entering study data into case report forms, databases, and source documentation in accordance with protocol and regulatory requirements.
• Monitor participant safety and study compliance by assessing eligibility, tracking adverse events, reviewing laboratory and test results, and ensuring all required procedures and data points are completed and documented.
• Manage sponsor communications, monitoring visits, data queries, enrollment logs, audits, and billing‑related activities to support successful execution of clinical research studies.
• Support regulatory compliance through adverse event reporting, regulatory submissions, training maintenance, and adherence to FDA, IRB, sponsor, and institutional requirements.

• Bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, or a directly related field; 2 years of professional experience in clinical research.
• Advanced degree (Masters or Doctorate) may substitute for experience on a year‑for‑year basis if the degree is in a field directly related to the work assignment.

• Experience with Phase I clinical research trials.
• Experience serving as a primary coordinator for clinical trials.
• Certification in clinical research (CCRC, CCRP, CCRA).
• Spanish fluency.
• Experience with electronic data capture systems (e.g., EMR/EHR and data management systems).

• Applicants must be legally authorized to work in the United States without requiring sponsorship.
• Eligible for a hybrid schedule of 4 days per week on campus with additional study activities; potential 5‑day week on campus based on business needs.

• Excellent written and oral communication skills.
• Strong interpersonal and customer‑service skills.
• Organization and time‑management skills.
• Leadership abilities.
• Ability to work on multiple research studies simultaneously.
• Advanced knowledge of GCP, FDA rules, NIH guidelines, ICH guidelines, HIPAA regulations, and NCI common toxicity definitions.
• Proficiency with clinical research coordinator duties and responsibilities.
• Understanding of phases and concepts of clinical trials and cooperative group research.
• Ability to interpret and master complex research protocol information.

$58,705 – $78,665 per year.

The University of Colorado is an equal‑opportunity employer. All qualified individuals are encouraged to apply. We are committed to creating a workplace where all individuals are treated with respect and dignity.