Clinical Research Project Coordinator

Sick Days: 15/year (unlimited maximum accrual)

University of Colorado Anschutz Medical Campus

Department:
Cancer Center - OCRST

Working Title:

Clinical Research Project Coordinator

Position #:  – Requisition #: 38723

This position will participate as a member of the Cancer Center’s Oncology Clinical Research Support Team (OCRST) in the development and implementation of Investigator Initiated research trials. The role involves writing and reviewing Investigator Initiated Trial (IIT) protocols, developing study tools such as PI oversight plans, registration forms, and other instructional materials needed to support IIT implementation and ongoing maintenance. The coordinator works closely with clinical research teams to operationalize IITs but is not responsible for patient recruitment.

Additional responsibilities include multicenter trial coordination tasks such as site feasibility evaluations, hosting teleconferences, and performing registration/randomization activities.

• Assist Cancer Center PIs in developing local Investigator Initiated protocols by providing clinical and operational expertise and reviewing for event consistency.
• Assist PIs in protocol development and amendments for Investigator Initiated Trials to ensure standardization and adherence to University, Cancer Center, FDA, and GCP policies and guidelines.
• Collaborate with clinical research managers and staff to assess feasibility, ensuring study as written is feasible for the disease site team and maintaining processes for smooth transition once the study opens; perform initial submission of IITs to PRMS and HSR Portal.
• Serve as primary contact for assigned trials, responsible for developing a communication plan, trial study tools, and other instructional materials for clinic teams.
• Perform administrative and oversight tasks for all participating institutions, including registration and randomization activities, coordinating regular teleconferences, and compiling data for reporting to DSMC or other regulatory or oversight entities.
• Communicate with Finance Professional and Contracts Associate to ensure budget and contract progress aligns with study activation activities; escalating as necessary to the PI and/or IIT Program Director.
• Collaborate with PI and Data Specialist to develop electronic case report forms using OnCore, REDCap, or Advarra databases.
• Assist PIs and study biostatisticians with dose escalation and interim safety analyses.
• Delegate and oversee tasks related to Investigator Initiated Trials Program as appropriate to program support staff or Data Specialist.
• Participate in activities related to the development of best practices for conducting IITs and multi‑center trials.
• Facilitate site evaluation and feasibility assessments for multi‑center Investigator Initiated Trials.

• Adhere to and conduct all duties related to Project Coordinator Level I.
• Independently manage and provide support for more complex Investigator Initiated Trials (e.g., multi‑site and Phase I trials) while delivering high‑level customer service.
• Recommend and draft enhancements to SOPs, guidance documents, or other tools/templates relevant to project coordination activities.
• Assist Clinical Research Project Manager in resolving issues using independent judgment, discretion, creativity, and analytical thinking.
• Participate in training clinical trial team staff on topics identified during communications, monitor visits, and audits.
• Participate in onboarding and training activities for new Project Coordinator team members; serve as backup coverage during team absences.
• Follow up and track all operational activities related to these responsibilities to ensure deliverables are executed according to agreed timelines.

• Adhere to and conduct all duties related to Project Coordinator Levels I and II.
• Act as mentor and planner for new Project Coordinator team members; provide backup coverage during absences.
• Prepare meeting presentations and deliver trainings during meetings.
• Independently draft proposals for enhancements to SOPs, guidance documents, or…