Clinical Research Project Coordinator

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. This position will participate in writing and review of Investigator Initiated Trial (IIT) protocols, develop study tools such as PI oversight plan, registration forms, and other instructional tools that are needed to support the implementation and ongoing maintenance of IITs.

This position works closely with clinical research teams to operationalize IITs but is not responsible for patient recruitment to clinical research projects. Performs tasks related to multicenter trial coordination including site feasibility evaluations, hosting teleconferences, and performing registration/randomization activities.

Level I Duties (Intermediate)

• Assists Cancer Center Principal Investigators (PIs) in the development of local Investigator Initiated protocols by providing clinical and operational expertise as well as review for consistency of events.
• Responsible for assisting PIs in the development of the protocol and subsequent amendments for Investigator Initiated Trials to ensure standardization and adherence to University and Cancer Center, FDA and GCP policies and guidelines for investigator initiated and multi-center trials.
• Works closely with the clinical research managers and staff in the areas where the trials will take place to ensure study as written is feasible for the disease site team; maintains processes that allow smooth transition of study to disease team once open. Perform initial submission of IITs to Protocol Review and Monitoring System (PRMS) and Human Subjects Research (HSR) Portal.
• Serves as primary contact for trials assigned and as such will be responsible for developing a communication plan as well as trial study tools and other instructional tools for the clinic teams.
• Performs administrative and oversight tasks for all participating institutions which may include registration and randomization activities, coordinating regular teleconferences with all participating institutions, compiling data for reporting to DSMC or other regulatory or oversight entity.
• Communicates with Finance Professional and Contracts Associate to ensure budget and contract progress in line with other study activation activities; elevate as necessary to PI and/or IIT Program Director.
• Works with PI and Data Specialist on development of electronic case report forms for trials utilizing OnCore, REDCap or Advarra databases.
• Assists PIs and study Biostatisticians with dose escalation and interim safety analyses.
• Delegates and oversees tasks related to Investigator Initiated Trials Program as appropriate to Program support staff or Data Specialist.
• Participates in activities related to development of best practices as related to conduct of IITs and multi-center trials.
• Facilitate site evaluation and feasibility assessments for multi-center Investigator Initiated Trials.

Level II Duties (Senior)

• Adheres to and conducts all duties related to the Project Coordinator Level I.
• Independently manages and provides support for more complex Investigator Initiated Trials (i.e. multi-site and Phase I trials) with a commitment to providing a high level of customer service.
• Recommends and drafts enhancements to SOP's, guidance documents or other tools/templates pertinent to project coordination activities.
• Assists Clinical Research Project Manager with resolving issues by utilizing independent judgement, discretion, creativity and analytical thinking.
• Participates in activities related to training of clinical trial team staff on topics identified during communications, monitor visits and audits.
• Participates in onboarding and training activities for new members of the Project Coordinator team; serves as back up coverage during team absences.
• Follow up and track all operational activities related to the above to ensure activities and deliverables are being…