Clinical Research Coordinator I (CRC 1)- Office of Clinical Research (OCR)

About the role

The job performs routine assignments related to the documentation and reporting of basic clinical studies. Supports decisions that impact clinical research conducted across the University. The Clinical Research Coordinator I- Office of Clinical Research (OCR) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI).

Responsibilities

• Cover all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of case report forms (CRFs), and adverse event (AE) reporting.
• Maintain accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, CRFs, drug/device accountability logs, and study-related communication.
• Perform specific protocol procedures (specimens and data management, survey/questionnaire administration, etc.) required to conduct the study and retain research subjects.
• Understand protocols and assist with identifying, collecting, and reporting adverse events (AEs) per protocol or investigator brochure.
• Plan and coordinate patient schedules for study procedures, return visits, and study treatment timelines.
• Ensure Standard Operating Procedures (SOPs) are implemented and documented in accordance with study sponsor, PI, and regulatory agency requirements.
• Prepare, submit, and maintain regulatory documentation, including IRB submissions, amendments, continuing reviews, and study-related materials.
• Aid investigators and research staff with reports to regulatory agencies (e.g., IRB, FDA, Data and Safety Review Committee).
• Organize and attend site visits from sponsors, including monitoring visits, audits, and other study-related meetings.
• Prepare for and participate in quality assurance audits conducted by study sponsors, federal agencies, or internal review groups.
• May recruit and screen potential study participants; may obtain, process, and transport specimens according to protocol and institutional guidelines.
• Act as a liaison with clinical staff, investigators, and ancillary departments to support study conduct.
• Maintain working knowledge of study protocols, manuals of operations, and internal SOPs.
• Follow procedures, maintain study records, track progress, and respond to data queries in a timely manner.
• Support clinical data management activities, including data collection, entry, verification, and query resolution; assist with retrieval of patient data and preparation of research charts.
• Assist with implementation of study goals and objectives, including enrollment planning and quality assurance activities.
• Accountable for all tasks in basic to moderately complex clinical studies.
• Assists with various professional, organizational, and operational tasks under direct supervision.
• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.
• Performs other related work as needed.

Requirements

Minimum requirements include a college or university degree in related field. Work Experience: Knowledge of medical terminology/environment. Preferred Qualifications: Education: Bachelor’s degree.