Senior Clinical Research Coordinator for Industry Trials

Revival-Research-Institute,-LL; Southfield (MI); On-site; USD 55,000 - 75,000; Full time

Job summary

Revival Research Institute, LLC is seeking an experienced site-based coordinator to independently manage industry-sponsored interventional trials from initiation through close-out. You will coordinate multiple studies, support investigators, and ensure regulatory and data integrity across visits, visits, and sponsor communications.

The role requires expertise in consent, EDC, FDA/HIPAA compliance, and on-site work in Southfield, Michigan.

Qualifications

• 2+ years as Clinical Research Coordinator on industry-sponsored interventional trials.
• Experience independently obtaining informed consent on interventional protocols.
• Hands-on experience with EDC platforms.
• Knowledge of ICH-GCP E6(R3) and 21 CFR Parts 11, 50, 54, 56, and 312, and HIPAA.
• Phlebotomy competency and IV certification preferred.
• Strong computer skills including MS Office; able to work independently.
• On-site work in Southfield, Michigan.

Responsibilities

• Screening, recruitment, and enrollment of study participants per protocol.
• Data collection, processing, and shipping of specimens as applicable.
• Enter data into EDC within sponsor timelines and resolve queries.
• Host monitoring visits and address findings through resolution.
• Maintain trial documents across regulatory binders and eRegulatory systems.
• Prepare regulatory documents and communicate with sponsors, labs, and vendors.
• Manage IP receipt, dispensing, and accountability per protocol.
• Maintain knowledge of ICH-GCP, FDA regulations, and HIPAA; training up to date.
• Protect participant confidentiality and support retention throughout the study.

Education

Master's degree in health-related field

Tools

EDC platforms

Job description

Revival Research Institute, LLC is seeking an experienced site-based coordinator to independently manage industry-sponsored interventional trials from initiation through close-out. You will coordinate multiple studies, support investigators, and ensure regulatory and data integrity across visits, visits, and sponsor communications.

The role requires expertise in consent, EDC, FDA/HIPAA compliance, and on-site work in Southfield, Michigan.