Clinical Research Coord Associate

SUMMARY The Clinical Research Coordinator Professional is an experienced Coordinator responsible for participating in the day‑to‑day operations of moderately complex clinical research programs and/or study portfolio 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. Supports the achievement of research program and/or study objectives. Works independently, under general supervision. SHIFT Colorado Child Health Research Institute - Heart Institute Monday – Friday, rare weekend coverage may be necessary depending on business needs. 8:00 AM – 5:00 PM Hybrid eligible, dependent on business need. ESSENTIAL FUNCTIONS Documentation/Data Collection – prepares and participates in site initiation, monitoring, closeout visits, document storage activities and related training. Assembles necessary parties to ensure that all required agreements are in place. Utilises and collaborates with senior team members on electronic data capture systems, technologies, and software necessary for clinical research program and/or study operations. Scores tests, enters data and completes required forms accurately and according to protocol. Supports the development of data collection documents and instruments, maintains subject level documentation, prepares documents, equipment and/or supplies, identifies issues and recommends solutions. Regulatory – submits assigned studies for review and approval and provides status updates throughout the startup process. Assists regulatory team with Institutional Review Board (IRB) preparation and submission. Study Participation – screens, schedules, consents participants in a variety of clinical research programs and/or studies. Explains the difference between clinical activities and research activities, risk and benefits of study participation to participants. Maintains participant recruitment and supports study retention and assists participants with individual needs. Collects information to determine feasibility, recruitment, and retention strategies. Collects, prepares, processes, ships, and maintains inventory of research specimens. Protocol – with guidance develops protocol‑specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Conducts and documents visits and testing/interviews according to all assigned regulatory and organisational protocols. With guidance completes and submits AE reports, according to institution and sponsor‑specific reporting requirements. Assists with the development of proposals or protocols as directed. Identifies and communicates related shortcomings. Maintains appropriate required systems related to documentation and dispensing, and tracks IP compliance at both protocol and subject level. Human Subject Research Protection – maintains compliance with institutional requirements and policies. Develops and maintains a familiarity with the ethical conduct of research and safeguards needed when conducting clinical research. Participates in and assists with the design of safeguards to ensure ethical conduct and to protect vulnerable populations and participates in sponsor required training. Assists with identifying issues related to professional guidelines and code of ethics. Identifies and escalates potential problems and risks to the participant, study and/or institution. Team Coordination – serves as backup for leading the team meetings. Proactively includes others in decision making and escalates issues to leadership as necessary. Contributes to the research work and activities of study teams. Participates in a committee or task force. As assigned, leads scientific or programmatic presentations. Identifies various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation and testing of clinical research programme and/or study aims. Collaborates with leadership team on determining operational elements needed for the conduct of clinical and translational programmes and/or studies. Quality Assurance – investigates incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Recognises and reports vulnerabilities related to security of physical and electronic data. Assists with recognising trends related to data quality and escalates as appropriate. Adheres to, participates in and provides support to quality assurance processes in collaboration with leadership. Assists with identifying issues related to operational efficiency and shares results with team members and management. With guidance recognises when data agreements or special regulatory requirements are necessary. Budgets/Financials – participates in monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing. Assists with the development of budgets. Mentoring/Coaching – assists with oversight, training and co‑mentoring team members working in the clinical research environment, specifically with the concepts of programme and/or study design. MINIMUM QUALIFICATIONS Education: Bachelor’s degree in a related field is required. Experience: Minimum of one (1) year of clinical, clinical support or clinical research experience. Equivalency: High school diploma or GED, and five (5) years of clinical related experience may be considered in lieu of minimum education requirement. Certification(s): None Licensure(s): None PREFERRED QUALIFICATIONS Research experience within a medical institute Research or clinical experience within cardiology Salary Information Pay is dependent on applicant’s relevant experience. Hourly Range: $22.42 to $33.63 Benefits Information Here, you matter. As a Children’s Hospital Colorado team member, you will receive a competitive pay and benefits package designed to take care of your needs that includes base pay, incentives, paid time off, medical/dental/vision insurance, company provided life and disability insurance, paid parental leave, 403(b) employer match (retirement savings), a robust wellness program, and access to professional development tools, including an education benefit to help you advance your career. As part of our Total Rewards package, Children’s Colorado offers an annual employee bonus program that rewards eligible team members based on organisational performance. If organisational goals are met for the year, the bonus is paid out the following April. Children’s Colorado delivers annual base pay increases to eligible team members based on their performance over the previous year. 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, colour, religion, national origin, sex, age, disability or any other status protected by law or regulation. Be aware that none of the questions are intended to imply illegal preferences or discrimination based on non‑job‑related information. The position is expected to stay open until the posted close date. Please submit your application as soon as possible as the posting is subject to close at any time once a sufficient pool of qualified applicants is obtained. Colorado Residents: In any materials you submit, you may redact or remove age‑identifying information such as age, date of birth or dates of attendance at or graduation from an educational institution. You will not be penalised for redacting or removing this information. #J-18808-Ljbffr