University of Colorado · 2 days ago
Clinical Research Project Coordinator
Aurora, CO
Full-time
Hybrid
Entry, Mid, Senior Level
$53K/yr - $66K/yr
1+ years expThe University of Colorado Anschutz Medical Campus is a leading institution in cancer research and patient care. They are seeking a Clinical Research Project Coordinator to support the development and implementation of Investigator Initiated research trials, collaborating closely with clinical research teams to ensure the feasibility and compliance of these trials.
EducationHigher EducationUniversities
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
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
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
Qualification
Required
BS or BA in Biology, Chemistry, Behavioral Science, Science, Health, Nursing or other related discipline
One (1) year of professional clinical research experience
Two (2) years of professional clinical research experience
Three (3) years of clinical research experience including at least two years of experience with project coordination of clinical trials
ACRP, SOCRA or RAC certification is required
Preferred
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
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
Four (4) years of clinical research experience including at least three years of experience with project coordination of clinical trials
Previous mentoring experience
Benefits
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.
Company
University of Colorado
University of Colorado offers higher education and serving as the catalysts in business, arts, health, and community growth.
10001+ employees
H1B Sponsorship
University of Colorado has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (184)
2024 (124)
2023 (163)
2022 (115)
2021 (86)
2020 (95)
Funding
Current Stage
Late StageTotal Funding
$0.5MKey Investors
US Department of EnergyUS Department of Commerce, Economic Development Administation
2023-07-27Grant
2023-01-26Grant
2021-04-06Grant· $0.5M
Leadership Team
Richard Schulick
Professor and Chair of Surgery
Recent News
Sports Business Journal
2025-12-28
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