Senior Clinical Research Coordinator On-Site Trials

Revival Research Institute, LLC; Southfield (MI); On-site; USD 65,000 - 90,000; Full time

Job summary

Revival Research Institute, LLC is seeking an experienced Clinical Research Coordinator to oversee interventional trials at our Southfield site. You will manage recruitment, consent, data capture in EDC, and regulatory documents, while coordinating with sponsors and IRBs.

Ideal candidates have 2+ years of site-based trial coordination, strong knowledge of ICH-GCP, HIPAA, and FDA_part_11 rules, plus phlebotomy and IV readiness.

Qualifications

• 2+ years as a Clinical Research Coordinator on industry-sponsored interventional trials.
• Demonstrated experience independently obtaining informed consent on interventional protocols.
• Hands-on experience with EDC platforms.
• Demonstrated experience hosting monitoring visits and resolving monitoring findings independently.
• Working knowledge of ICH-GCP E6(R3) and 21 CFR Parts 11, 50, 54, 56, and 312, and HIPAA.
• Current phlebotomy competency, and IV certification preferred.
• Proficiency in conducting physical assessments, including vital signs and 12-lead ECG acquisition.
• Master's degree in health-related field, or equivalent site experience.
• Strong computer proficiency including Microsoft Office; excellent verbal and written communication; ability to work independently.
• Ability to work on-site in Southfield, Michigan.

Responsibilities

• Screening, recruitment, and enrollment.
• Data and monitoring: enter data in EDC and resolve queries.
• Regulatory and quality: manage trial documents and systems.
• Sponsor and IRB communication: prepare regulatory submissions.
• Investigational product accountability: IP receipt, dispensing, reconciliation, storage.
• Maintain knowledge of ICH-GCP and FDA regulations; ensure training.
• Participant communication and confidentiality: protect HIPAA compliance.

Skills

Clinical Research Coordination

Informed consent

EDC platforms

Monitoring visits

ICH-GCP HIPAA knowledge

Phlebotomy competency / IV

Vital signs / ECG

MS Office

On-site work in Southfield MI

Education

Master's degree in health-related field

Tools

EDC platforms

Microsoft Office

Job description

Revival Research Institute, LLC is seeking an experienced Clinical Research Coordinator to oversee interventional trials at our Southfield site. You will manage recruitment, consent, data capture in EDC, and regulatory documents, while coordinating with sponsors and IRBs.

Ideal candidates have 2+ years of site-based trial coordination, strong knowledge of ICH-GCP, HIPAA, and FDA_part_11 rules, plus phlebotomy and IV readiness.