Clinical Research Coordinator II

Corewell Health • Royal Oak, MI

8d • Onsite

About The Position

This role may function as study personnel, a regulatory specialist, or an auditor. As study personnel, the CRC II is responsible for protocol coordination, including subject recruitment, enrollment, implementation, and follow-up of appropriate research protocols. The CRC II promotes good clinical practice by possessing knowledge of federal regulations and guidance documents for clinical trials and human subject protection. As a Regulatory Specialist, the CRC II comprehensively coordinates all processes related to HIC business to ensure compliance with institutional policies and federal regulations governing human subject research. As an Auditor, the CRC II provides ongoing review of all patient and regulatory materials based on Good Clinical Practices, evaluating accuracy and completeness of documents per regulatory, institutional, and study-specific requirements. Auditor activities include, but are not limited to, review of subject eligibility and screening procedures, review of subject research visits and data collection, and review of CRFs, source documents, and other essential documents.

Requirements

• 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.
• Good working knowledge of all applicable FDA guidelines and Good Clinical Practices.
• Basic Life Support (BLS) certification from AHA or ARC upon hire.
• Clinical Research Professional, Certified (CCRP) - SOCRA Society of Clinical Research Associates upon hire.
• Clinical Research Coordinator, Certified (CCRC) - ACRP Association of Clinical Research Professionals upon hire.
• IRB Professional, Certified (CIP) upon hire.

Nice To Haves

• Clinical specialist with technician registration or therapist licensure (e.g., Radiation Therapist, Cardiovascular Specialist) and National Research Certification within six months of eligibility.

Responsibilities

• Protocol coordination, including subject recruitment, enrollment, implementation, and follow-up of appropriate research protocols.
• Promote good clinical practice in the conduct of clinical investigations.
• Comprehensively coordinate all processes related to HIC business in order to insure compliance with institutional policies and federal regulations governing human subject research.
• Provide ongoing review of all patient and regulatory materials based on Good Clinical Practices.
• Evaluate accuracy and completeness of documents per regulatory, institutional and study specific requirements.
• Review of subject eligibility and screening procedures.
• Review of subject research visits and data collection.
• Review of CRF's, source documents and other essential documents.

Benefits

• Comprehensive benefits package to meet your financial, health, and work/life balance goals.
• On-demand pay program powered by Payactiv
• Discounts directory with deals on the things that matter to you, like restaurants, phone plans, spas, and more!
• Optional identity theft protection, home and auto insurance
• Traditional and Roth retirement options with service contribution and match savings

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level