Clinical Research Coordinator III

Job Description:

Quality Assurance and Oversight • Conduct periodic quality assurance reviews of clinical research documentation, including source data, case report forms, and regulatory files, to ensure GCP and institutional compliance. • Identify findings, develop corrective and preventive action (CAPA) plans, and track resolution through completion. • Support readiness for sponsor, federal, and internal audits by maintaining accurate and complete research documentation. • Develop and deliver QA tools, checklists, and training resources for study teams and faculty. OnCore CTMS Management • Ensure data integrity and standardization across protocols, coordinating with research finance, compliance, and departmental teams. • Generate OnCore reports to support leadership oversight and operational decision-making. Veeva eRegulatory System • Oversee the maintenance of electronic regulatory binders in Veeva eRegulatory to ensure complete, accurate, and compliant documentation. • Conduct regular quality control checks of study regulatory files and assist in resolving discrepancies. • Support and train faculty and staff in the use of Veeva for document submission, routing, and approval workflows. IRB and Regulatory Compliance • Liaise between the study team, IRB, and other institutional offices to ensure timely and compliant submissions. • Maintain awareness of current institutional, federal, and sponsor regulations impacting human subjects research. Expected Salary:

$,- $, per year

Required Qualifications:

Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

Preferred: Master's degree or an allied health professional degree in an appropriate area and 5 years of experience coordinating or managing clinical research in an academic medical center or hospital-based environment, preference for experience in performing quality assurance reviews on clinical trial adherence. Education & Experience: • Bachelor’s degree in a health-related, scientific, or regulatory discipline and three years of relevant experience; or an equivalent combination of education and experience. • Demonstrated experience using CTMS, eRegulatory, and electronic IRB submission systems. • Strong knowledge of ICH-GCP, FDA, OHRP, and institutional research regulations and standards. Skills & Competencies: • High attention to detail and strong organizational skills. • Excellent interpersonal, written, and verbal communication abilities. • Ability to manage multiple priorities and meet deadlines in a complex academic environment. • Proven ability to work collaboratively across departments and disciplines. • Proficiency with Microsoft Office Suite and research management applications.