Clinical Research Coordinator Sr - Fetal Care Center

Job Overview Summary 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. Performs a variety of administrative and operational duties involved in the collection, compilation, documentation, and review of clinical research data. Facilitates the accomplishment of research programs and/or study goals. Works independently and leads others in navigating the clinical research environment and participates in a variety of departmental and/or divisional initiatives. Provides oversight to Clinical Research Coordinators and other related team members. Works under minimal supervision. This position will support the Colorado Fetal Care Center, which offers comprehensive, world‑class testing, diagnosis, treatment and care for unborn babies and moms‑to‑be. As a leading center for high‑risk pregnancies, we manage and treat higher volumes of rare fetal conditions, thereby improving experience. Shift Day shift, 08:00 a.m. – 16:30 p.m. May require occasional weekend coverage. Hybrid eligible. Duties & Responsibilities Prepare and support site initiation, monitoring, closeout visits, document storage, training, creation of SOPs, and implementation of operational plans. Assemble necessary parties to ensure all required agreements are in place. Assist team members in training on electronic data capture systems, technologies, and software necessary for clinical research program and/or study operations. Score tests, enter data, and complete required forms accurately and according to protocol. Lead development of data collection documents and instruments, maintain subject‑level documentation, and prepare documents, equipment and/or supplies; identify issues and recommend solutions. Identify and liaise with regulatory partners (IRB, compliance, legal) as needed to support research operations. Identify gaps and participate in policy, SOP, and guideline development to enhance research operations. Submit assigned studies for review and approval; provide status updates throughout the startup process. Assist regulatory team with Institutional Review Board (IRB) preparation and submission. Screen, schedule, and consent participants in a variety of clinical research programs and/or studies. Explain the difference between clinical activities and research activities, risk and benefits of study participation to participants. Conduct difficult, sensitive conversations with patients/families. Employ, evaluate, and assist with innovative solutions to maximize recruitment and retention, and assist participants with individual needs. Collect information to determine feasibility, recruitment, and retention strategies. Collect, prepare, ship, and maintain inventory of research specimens. Develop and optimize protocol‑specific systems and documents including process flows, training manuals, SOPs and CRFs. Conduct and document visits and testing/interviews according to all regulatory and organizational protocols. Complete and submit AE reports with regulatory team, according to institution and sponsor‑specific reporting requirements. Serve as a resource regarding institutional and sponsor‑specific reporting requirements. Assist with proposal or protocol development; identify and communicate related shortcomings. Maintain appropriate documentation and track IP compliance at both protocol and subject level. Ensure compliance with institutional requirements and policies for human subject research protection. Develop familiarity with ethical conduct of research and safeguards needed during clinical research. Train on sponsor‑required training and code of ethics. Identify and resolve potential problems and risks to participants, study and/or institution. Lead team meetings. Proactively include others in decision making and escalates issues to leadership as necessary. Provide significant contribution and influence upon research work, activities and/or productivity of study teams. Lead a committee or task force under direction of a supervisor. Lead scientific or programmatic presentations. Identify stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of clinical research program and/or study aims. Implement operational elements needed for conduct of clinical and translational programs and/or studies. Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness; assist management with resolution. Recognize vulnerabilities related to data security. Recognize trends related to data quality and implement retraining as appropriate. Adhere to and oversee development and assessment of quality assurance processes. Identify issues related to operational efficiency and share results with team members and management. Recognize when data agreements or special regulatory requirements are necessary; act as a resource and mentor to determine when special contracts are required and escalated to stakeholders. Develop systems or frameworks for quality assurance processes in collaboration with leadership. Participate in and provide oversight of monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing. Comprehensive understanding of institutional budgeting process. Proactively identify gaps and deficits and escalated. Provide oversight, training and coaching to team members working in the clinical research environment, specifically with the concepts of program and/or study design. Minimum Qualifications Degrees : Bachelor of General Studies Area of Study : No specific area of study Experience : Three (3) years of clinical, clinical support, and/or clinical research related experience Equivalency : None Licenses & Certifications : None Additional Requirements : Associate degree in a related field with five (5) years of clinical related experience may be considered in lieu of the minimum education requirement Competency : None Preferred Qualifications Clinical, patient‑facing experience Salary Information Hourly Range: $25.95 to $38.93. Pay is dependent on applicant's relevant experience. Benefits Information As a Children’s Hospital Colorado team member, you receive a competitive pay and benefits package including base pay, incentives, paid time off, medical/dental/vision insurance, company‑provided life and disability insurance, paid parental leave, 403(b) employer match, a robust wellness program, and access to professional development tools, including an education benefit. Children’s Colorado offers an annual employee bonus program based on organizational performance, paid in April if goals are met. Base pay increases are awarded annually based on performance. EEO Statement It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job‑related factors. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law or regulation. The position is expected to stay open until the posted close date. Colorado Residents may redact age‑identifying information in any submitted materials without penalty. #J-18808-Ljbffr