Senior On-Site CRC - Interventional Trials

Revival-Research-Institute,-LL; Hamilton Township (NJ); On-site; USD 60,000 - 90,000; Full time

Job summary

Revival Research Institute, LLC is seeking an experienced site-based coordinator to lead industry-sponsored interventional trials from initiation to close-out. This on-site role requires independent management of assigned protocols, coordination with Investigators, staff, and sponsors, and strict adherence to ICH-GCP and regulatory requirements in a multi-site setting.

Responsibilities include screening and enrollment, data entry in EDC, regulatory documentation, IP accountability, and ensuring

Qualifications

• 2+ years as a Clinical Research Coordinator at a site, leading industry-sponsored interventional trials.
• Experience obtaining informed consent on interventional protocols.
• Hands-on experience with EDC platforms.
• Experience hosting monitoring visits and resolving monitoring findings independently.
• Knowledge of ICH-GCP E6(R3) and 21 CFR Parts 11, 50, 54, 56, and 312, and HIPAA.

Responsibilities

• Screening, recruitment, and enrollment.
• Data entry into EDC and monitoring.
• Regulatory and quality documentation ownership.
• Sponsor and IRB communication.
• Investigational product accountability management.
• Maintain knowledge of regulatory requirements and conduct training.

Skills

EDC platforms

ICH-GCP E6(R3) knowledge

HIPAA knowledge

Communication skills

Independent study ownership

Education

Master's degree in health-related field

Tools

Microsoft Office

IP accountability systems

Job description

Revival Research Institute, LLC is seeking an experienced site-based coordinator to lead industry-sponsored interventional trials from initiation to close-out. This on-site role requires independent management of assigned protocols, coordination with Investigators, staff, and sponsors, and strict adherence to ICH-GCP and regulatory requirements in a multi-site setting.

Responsibilities include screening and enrollment, data entry in EDC, regulatory documentation, IP accountability, and ensuring