Clinical Research Coordinator Sr - Fetal Care Center

The Clinical Research Coordinator Senior is a seasoned Coordinator who can work across multiple complex modalities and is responsible for participating in the day-to-day operations of complex, multi-site clinical research programs and/or studies conducted by Principal Investigators (PIs) at the University of Colorado Anschutz Medical Campus. This position supports the Colorado Fetal Care Center, which provides comprehensive, world-class testing, diagnosis, treatment, and care for unborn babies and expectant mothers, specializing in high-risk and rare fetal conditions.

Responsibilities

• Prepares and participates in site initiation, monitoring, closeout visits, and document storage activities; creates SOPs and implements operational plans.
• Assembles necessary parties to ensure all required agreements are in place for research programs/studies.
• Utilizes and trains team members on electronic data capture systems, technologies, and software for clinical research operations.
• Scores tests, enters data, and completes required forms accurately according to protocol.
• Leads the development of data collection documents and instruments; maintains subject-level documentation and prepares supplies.
• Identifies issues and recommends solutions for research operations.
• Liaises with regulatory partners (IRB, compliance, legal) to support research operations.
• Identifies gaps and participates in policy, SOP, and guideline development to enhance research operations.
• Submits studies for review and approval; provides status updates during the startup process.
• Assists with IRB preparation and submission.
• Screens, schedules, and consents participants; explains clinical vs. research activities, risks, and benefits.
• Conducts sensitive conversations with patients/families; implements recruitment and retention strategies.
• Collects, prepares, processes, ships, and maintains inventory of research specimens.
• Develops protocol-specific systems, including process flows, training manuals, SOPs, and CRFs.
• Conducts and documents visits/testing/interviews according to regulatory and organizational protocols.
• Completes and submits AE reports according to institutional and sponsor-specific requirements.
• Serves as a resource for institutional and sponsor-specific reporting requirements.
• Assists with proposal/protocol development; identifies and communicates shortcomings.
• Maintains documentation and tracks IP compliance at protocol and subject levels.
• Ensures compliance with institutional requirements and ethical conduct of research; designs safeguards for vulnerable populations.
• Serves as a resource and trainer for professional guidelines, code of ethics, and sponsor-required training.
• Identifies and resolves potential problems/risks to participants, studies, or the institution.
• Leads team meetings, proactively includes others in decision-making, and escalates issues to leadership.
• Provides significant contributions to research work, activities, and study team productivity.
• Leads committees, task forces, or scientific/programmatic presentations under supervisor direction.
• Identifies stakeholders (statistical, operational) to ensure adequate design, implementation, and testing of research aims.
• Implements operational elements for clinical and translational programs/studies with the leadership team.
• Investigates incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness.
• Recognizes and reports vulnerabilities related to physical and electronic data security.
• Assists with identifying data quality trends and implements retraining as needed.
• Adheres to and oversees quality assurance processes; identifies operational efficiency issues and shares results.
• Recognizes when data agreements or special regulatory requirements are necessary; mentors team members on contract needs.
• Develops quality assurance frameworks in collaboration with leadership.
• Monitors financial study milestones, reporting, and ensures appropriate financial routing for participant care expenses.
• Demonstrates comprehensive understanding of institutional budget development processes; proactively identifies gaps.
• Provides oversight, training, and coaching to team members on program/study design concepts.

Requirements

• Bachelor’s degree (or Associate degree in a related field with 5 years of clinical experience).
• Three (3) years of clinical, clinical support, or clinical research-related experience.
• Clinical or patient-facing experience (preferred).

Schedule

• Day shift: 08:00 a.m. – 16:30 p.m.
• Occasional weekend coverage may be required.
• Hybrid eligible.

Pay

Hourly range: $25.95 to $38.93, dependent on relevant experience.

Benefits

• Competitive pay and benefits package, including base pay and incentives.
• Paid time off, medical/dental/vision insurance, and company-provided life/disability insurance.
• Paid parental leave and 403b employer match (retirement savings).
• Robust wellness program and access to professional development tools, including an education benefit.
• Annual employee bonus program based on organizational performance (paid the following April if goals are met).
• Annual base pay increases based on performance.