Clinical Research Project Coordinator

Clinical Research Project Coordinator Description University of Colorado Anschutz Medical Campus Department: Cancer Center - OCRST Working Title: Clinical Research Project Coordinator Position #: 00756542 - Requisition #: 38723 Job Summary: 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 Why Join Us: Why work for the University? + Medical: Multiple plan options + Dental: Multiple plan options + Additional Insurance: Disability, Life, Vision + Retirement 401(a) Plan: Employer contributes 10% of your gross pay + Paid Time Off: Accruals over the year + Vacation Days: 22/year (maximum accrual 352 hours) + Sick Days: 15/year (unlimited maximum accrual) + Holiday Days: 10/year + Tuition Benefit: Employees have access to this benefit on all CU campuses + ECO Pass: Reduced rate RTD Bus and light rail service + There are many additional perks & programs with the CU Advantage (. Qualifications: 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. Project Coordinator Level II (Senior) + 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. + Two (2) years of professional clinical research experience. Project Coordinator III (Principal Professional) + 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. + Three (3) years of clinical research experience including at least two years of experience with project coordination of clinical trials. For this position, project coordination is defined as management of the clinical research projects and activities to ensure compliance with protocols and overall clinical objectives. This will include directing all aspects of clinical trial team activities for assigned projects with respect to site selection, project plans and tools, trial budget and timeline management, data collection and analysis, quality standards and risk mitigation. + ACRP, SOCRA or RAC certification is required. Preferred Qualifications: Project Coordinator I + Three or more years of research experience in an academic setting + One year experience with investigator initiated multi-center studies + Experience operationalizing clinical research studies + Prior oncology experience Project Coordinator II + Three (3) years of professional clinical research experience including at least two years of experience with project coordination of clinical trials. For this position, project coordination is defined as management of the clinical research projects and activities to ensure compliance with protocols and overall clinical objectives. This will include directing all aspects of clinical trial team activities for assigned projects with respect to site selection, project plans and tools, trial budget and timeline management, data collection and analysis, quality standards and risk mitigation. + Understanding of medical terminology and technical writing experience + Oncology research experience + Experience working with investigator-initiated research + Experience working in an academic setting + Thorough knowledge of ICH/FDA guidelines + Current Clinical Research Certification (CCRC, CCRA, CCRP) or meets criteria to sit for exam within one year Project Coordinator III + Four (4) years of clinical research experience including at least three years of experience with project coordination of clinical trials. For this position, project coordination is defined as management of the clinical research projects and activities to ensure compliance with protocols and overall clinical objectives. This will include directing all aspects of clinical trial team activities for assigned projects with respect to site selection, project plans and tools, trial budget and timeline management, data collection and analysis, quality standards and risk mitigation. + Understanding of medical terminology and technical writing experience + Previous mentoring experience + Oncology research experience + Experience working with investigator-initiated research + Experience working in an academic setting + Thorough knowledge of ICH/FDA guidelines Knowledge, Skills and Abilities: + Ability to problem solve and multi-task. + Excellent computer skills. Proficient in Windows, MS Word, Excel. + Possesses knowledge of Good Clinical Practices Manual, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials, and NCI common toxicity definitions. + Possesses an understanding of the phases and concepts of clinical trials and the overall philosophies of conducting cooperative group research as they differ with NCI sponsored, private industry and investigator initiated clinical trials. + Knowledge of basic human anatomy, physiology, medical terminology. + Ability to communicate effectively and with a high level of professionalism across various stakeholders. + Proficient in writing or creating documentation such as SOPs, guidance documents or other similar documents How to Apply: 1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position (only use if a cover letter is necessary) 2. Curriculum vitae / Resume 3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address Screening of Applications Begins: January 22, 2026 Anticipated Pay Range: + Level I (Intermediate): $52,721 + Level II (Senior): $56,995 + Level III (Principal): $65,545 Equal Employment Opportunity Statement: Background Check Statement: Vaccination Statement: Job Category Primary Location Schedule Posting Date Unposting Date To apply, visit ( Copyright 2025 Inc. All rights reserved. Posted by the FREE value-added recruitment advertising agency ( Clinical Research Project Coordinator - 38723 University Staff 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. - this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings. The University of Colorado Cancer Center (of Colorado Cancer Center) stands at the forefront of cancer research and patient care in Colorado. As the state's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, we hold a prestigious distinction that acknowledges our exceptional contributions to the fields of research, clinical trials, prevention, and cancer control. Our guiding vision is clear:

Created: 2026-01-19