Clinical Research Coordinator

Job Description Summary

Assists in the management of clinical trials under direct supervision by coordinating patient screening, enrollment, data collection, and sample handling. Supports IRB submissions and helps prepare manuscripts, grant proposals, and presentations. Works closely with the Principal Investigator, manager, and study team to address study needs, implement approved changes, and monitor outcomes. Contributes to investigator-initiated, multi-center, and patient-oriented clinical and translational research studies.

Job Responsibilities

• Adhere to an IRB approved protocol
• Participate in the informed consent process of study subjects
• Support the safety of clinical research patients/research participants
• Coordinate protocol related research procedures, study visits, and follow-up care
• Screen, recruit and enroll patients/research participants
• Maintain study source documents
• Report adverse events
• Understand good clinical practice (GCP) and regulatory compliance
• Educate subjects and their support members on protocol, study intervention, etc.
• Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
• Manage essential regulatory documents
• Register and keep study up to date on CRMS
• Complete case report forms and address queries
• Submit documents to regulatory authorities
• Facilitate pre-study, site qualification, study initiation, and monitoring visits
• Collect, process and ship laboratory specimens
• Other duties as assigned

Qualifications

Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.