"Clinical Research Project Coordinator"

Clinical Research Project Coordinator

University of Colorado Anschutz Medical Campus

Department: Cancer Center - OCRST

Position #: 00756542 - Requisition #: 38723

Job Summary:

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.

Key Responsibilities:

• 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; escalate 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 executed according to agreed upon timelines.

Level III Duties (Principal Professional)

• Adheres to and conducts all duties related to the Project Coordinator Level I and II.
• Acts as mentor to and participates in planning for and onboarding activities for new members of the Project Coordinator team; serves as back up coverage during team absences.
• Prepare meeting presentations and/or deliver trainings during meetings.
• Independently drafts proposals for enhancements to SOP's, guidance documents or other tools/templates pertinent to project coordination activities.
• Takes on special projects for team development (i.e. meeting with collaborators to refine/expand processes, development of new workflows, etc.).
• Assists Clinical Research Project Manager in defining areas for improvement around protocol development, data analysis, etc.
• Delegate and oversee tasks assigned to Data Specialist on projects in which acting as the primary project coordinator
• Acts as work lead in the collection and management of protocol data to inform process evaluations, team workload and performance metrics; may involve developing and implementing new processes and reports to improve effectiveness and efficiency of data collection and process evaluation.
• Manage more complex protocols in which new processes may need to be defined and act as subject matter expert to train other project coordinators on these processes to be instituted on subsequent trials.

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

Why Join Us: The University of Colorado Cancer Center stands at the forefront of cancer research and patient care in Colorado...

Minimum Qualifications:

Project Coordinator Level I (Intermediate)

• BS or BA in Biology, Chemistry, Behavioral Science, Science, Health, Nursing or other related discipline.
• Substitution: A combination of education and clinical research or project coordination experience can substitute for the degree on a year for year basis.
• One (1) year of professional clinical research experience.

Preferred Qualifications:

Knowledge, Skills and Abilities:

• Ability to problem solve and multi-task.

Anticipated Pay Range:

• Level I (Intermediate): $52,721
• Level II (Senior): $56,995
• Level III (Principal): $65,545