Clinical Research Coordinator II

Corewell Health • Royal Oak, MI

2d • Onsite

About The Position

Corewell Health William Beaumont University Hospital opened on Jan. 24, 1955 as a 238-bed community hospital. Today, the hospital is a 1,101-bed major academic and referral center with Level I adult trauma and Level II pediatric trauma designations. Corewell Health William Beaumont University Hospital has 43 residency and fellowship programs with 454 residents and fellows. Corewell is the exclusive clinical partner of the Oakland University William Beaumont School of Medicine, with more than 1,400 doctors on faculty.

The CRC II study personnel is responsible for protocol coordination, including subject recruitment, enrollment, implementation, and follow-up of appropriate research protocols. The CRCII study personnel promotes good clinical practice in the conduct of clinical investigations by possessing knowledge of federal regulations and guidance documents for the conduct of clinical trials and human subject protection. The CRC II Regulatory Specialist comprehensively coordinates all processes related to HIC business in order to insure compliance with institutional policies and federal regulations governing human subject research. The CRC II Auditor provides ongoing review of all patient and regulatory materials based on Good Clinical Practices. The CRC II Auditor evaluates accuracy and completeness of documents per regulatory, institutional and study specific requirements. The Auditor's activities will include but are not limited to, review of subject eligibility and screening procedures, review of subject research visits and data collection and review of CRF's, 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, OR clinical specialist with technician registration or therapist licensure (e.g., Radiation Therapist, Cardiovascular Specialist) and National Research Certification within six months of eligibility.
• Good working knowledge of all applicable FDA guidelines and Good Clinical Practices.

Nice To Haves

• Clinical Research Professional, Certified (CCRP) - SOCRA Society of Clinical Research Associates
• Clinical Research Coordinator, Certified (CCRC) - ACRP Association of Clinical Research Professionals
• IRB Professional, Certified (CIP) - UNKNOWN Unknown
• Basic Life Support (BLS) - AHA American Heart Association
• Basic Life Support (BLS) - ARC American Red Cross

Responsibilities

• Protocol coordination, including subject recruitment, enrollment, implementation, and follow-up of appropriate research protocols.
• Promotes good clinical practice in the conduct of clinical investigations by possessing knowledge of federal regulations and guidance documents for the conduct of clinical trials and human subject protection.
• Comprehensively coordinates all processes related to HIC business in order to insure compliance with institutional policies and federal regulations governing human subject research.
• Provides ongoing review of all patient and regulatory materials based on Good Clinical Practices.
• Evaluates 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