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
• Must comply with federal, state, and sponsor policies
• Manage essential regulatory documents
• Register and keep study up to date on CRMS
• Complete case report forms (paper & electronic data capture) and address queries
• Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer)
• Facilitate pre-study, site qualification, study initiation, and monitoring visits
• Facilitate study close out activities
• Assist project manager(s) with study start-up
• Attend and participate in team meetings
• Collect, process and ship laboratory specimens
• Schedule subject visits and procedures in EMR and keep track of visits
• Complete subject visits per protocol in accordance to GCP
• Retain records/archive documents after study close out
• Develop Case Report Forms/Smartphrases in the EMR
• Develop/edit informed consent document
• Apply in depth knowledge of clinical research and independently coordinate the activities of 1 or more large-scale, complex multi-center / multi-institutional studies
• Accountable for study oversight at one or more sites/institutions
• Prepares study sites for internal/external regulatory audits (sponsor, FDA, NIH, etc)
• Educates internal and external clinical staff, research teams and other coordinators; provides resources, and consulting on difficult protocols or projects
• Assesses and critiques protocol feasibility and provides recommendations
• May support 1 or more PI sponsored INDs or IDEs
• Liaises between Research billing and the research team
• Assist fellow research coordinators with studies as needed
• Act as liaison for research subject, investigator, IRB, and sponsor.
• Other duties and responsibilities as assigned