Clinical Study Coordinator

About the Role

The Population Sciences Research Infrastructure, Systems, and Management has an immediate opening for a Clinical Study Coordinator in the Population Sciences Trials Office and Adapt team at the Huntsman Cancer Institute. The coordinator will assist the Principal Investigator(s) in completion of sound, ethical, and compliant research aimed at improving the lives of people who have cancer or prevent cancer altogether. This role oversees research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies.

Key Responsibilities

• Support the clinical Principal Investigator (PI) in daily trial activities.
• Assist Principal Investigators in achieving study objectives by implementing and completing study protocols and procedures.
• Explain and obtain informed consent, medical history, and demographics; document in the source file and maintain with historical data, status reports, progress notes, and subject logs to help ensure subject safety.
• Assess protocol for clarity and subject safety, review inclusion/exclusion criteria; clarify concerns and questions with Principal Investigator and sponsor.
• Participate in participant recruitment and consent processes, helping ensure accurate documentation management throughout the study.
• Attend and participate in Investigator and staff meetings. Advise team regarding specific study assignments and timelines.
• Determine length of visits and coordinate related facility and equipment availability.
• Coordinate study visits and help ensure the availability of necessary resources for successful study outcomes.
• Complete, audit, and correct CRFs (Case Report Forms), and relay CRFs to sponsor.
• Complete and audit case report forms (CRFs) for accuracy, with guidance as needed.
• Maintain documents as required by FDA guidelines.
• May maintain contact with IRB and prepare and submit IRB documents.
• May ensure proper collection, processing, and shipment of specimens.
• Manage communication and problem-solving related to study execution.
• Collect, compile, and enter data into the study electronic data capture system.
• Schedule appointments, visits, and meetings.
• Perform quality control through audits to resolve discrepancies and overlaps with data.
• Assist CRC and Sr CRC with preparing for audit and monitoring visits.
• Assist in protocol modifications.
• Ensure training requirements are met for study personnel.
• Cooperate with compliance efforts related to sponsored program administration and human research participant protection.
• Report and track adverse events (AE) and report them to the study lead(s). Report serious AEs to study leads to inform IRB and sponsor.
• Document all protocol deviations, reconcile test article accountability at study close out, and may assist in preparing summary reports for sponsor.
• Report to the program manager and senior clinical research coordinator (if applicable) for study-related items and the clinical research manager.
• Provide back-up team coverage when needed.
• Uphold institutional and departmental expectations and policies.

Requirements & Tech Stack

• Clinical Study Coordinator (potentially at I level)
• Experience with EPIC
• Experience with electronic data capture systems, like REDCap

Qualifications

• Bachelor's degree in a related field, or equivalency.
• 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor's degree = 4 years of directly related work experience).
• Exceptional organizational skills.
• Attention to detail.
• Demonstrated human relations skills.
• Effective communication skills.
• Knowledge of Good Clinical Practices.
• Knowledge of FDA regulations.
• Knowledge of HIPAA regulations.
• Knowledge of IRB regulations.
• Experience with the IRB.
• Experience with ERICA.
• Ability to work as part of a team.
• Ability to work independently.
• IRB CITI Course in the Protection of Human Research subjects certificate obtained within six months of hire.
• This position is patient-sensitive and must fulfill all associated requirements. Employees must be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs.
• Work may include supporting investigator-initiated studies and sponsored projects.
• Employees may have a hybrid work schedule after completing a probationary period, working both remotely as well as on-site.
• Employees may need to provide their own home office space, internet connection, telephone, and have the ability to work independently.