Clinical Research Coordinator II

About the role

The CRC II study personnel, CRC II Regulatory Specialist, and CRC II Auditor roles at Corewell Health William Beaumont University Hospital (Royal Oak) are responsible for various aspects of clinical research, including protocol coordination, regulatory compliance, and auditing.

Responsibilities

• Function as study personnel, regulatory specialist, or auditor.
• Coordinate protocol implementation, enrollment, and follow-up for research protocols.
• Promote good clinical practices by adhering to federal regulations and guidance documents.
• Comprehensively coordinate all processes related to Human Institutional Committee (HIC) business to ensure compliance with institutional policies and federal regulations.
• Review patient and regulatory materials based on Good Clinical Practices.
• Evaluate accuracy and completeness of documents according to regulatory, institutional, and study-specific requirements.
• Assess subject eligibility and screening procedures, review subject research visits and data collection, and evaluate CRFs, source documents, and other essential documents.

Qualifications

• Required: Bachelor's Degree or equivalent in a health-related field, two or more years of clinical research experience, and National Research Certification within six months of hire OR five or more years of clinical research experience, and National Research Certification.
• Preferred: CRT certification from the preferred list.
• Must have good working knowledge of applicable FDA guidelines and Good Clinical Practices.

How Corewell Health cares for you

Corewell Health offers a comprehensive benefits package, including a traditional and Roth retirement option with service contribution and match, discounts, identity theft protection, and home and auto insurance.