Clinical Research Coordinator II

Royal Oak - Full time, day shift

Job Summary

The Clinical Research Coordinator II may function as study personnel, regulatory specialist or auditor. 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.

Essential Functions

• Participate in subject screening, recruitment, enrollment and follow-up procedures, pre-study preparation, problem solving and maintenance of clinical trials. Collect, process and ship research specimens, including blood draws with appropriate and specific training. Document all study-related procedures/events in documents, including CRFs or EDC, participate in monitor visits, review of CRF with sponsor and handle data queries. Consent and conduct study visits for trials as appropriate to education, training, and work experience. Consent for minimal risk trials, independently. Consent for greater than minimal risk trials as delegated and overseen by a Research Nurse Clinician. Monitor for AEs, distribute device study article and monitor device study article accountability as appropriate.
• Prepare and/or review complex regulatory documents such as IRB Applications, Informed Consents, complex Amendments, Progress Reports, Adverse Event Reports, and Protocol Deviations per FDA and OHRP regulations.
• Review and process requests for approval of research protocols submitted to the IRB. Review research consent to determine consistency with guidelines. Work with submitting investigator to provide instruction on submission requirements and remedy deficiencies in submitted documentation.
• Communicate effectively with subjects, key research personnel, IRB, ancillary staff, study sponsors, and primary care providers in accordance with Beaumont hospitality standards.
• Prepare for and participate in sponsor and external regulatory audits and departmental audits, including review of study and regulatory documents for accuracy and completeness.
• Patient/Family interaction - utilizes effective communication skills, incorporate specific age, cultural, or developmental needs.
• Maintain technical and professional expertise.

Qualifications

• Required Bachelor's Degree 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.

• Must have good working knowledge of all applicable FDA guidelines and Good Clinical Practices. Required

• CRT-At least one Certification from preferred list - UNKNOWN Unknown Upon Hire preferred
• CRT-Clinical Research Professional, Certified (CCRP) - SOCRA Society of Clinical Research Associates Upon Hire preferred Or
• CRT-Clinical Research Coordinator, Certified (CCRC) - ACRP Association of Clinical Research Professionals Upon Hire preferred Or
• CRT-IRB Professional, Certified (CIP) - UNKNOWN Unknown Upon Hire preferred
• CRT-Basic Life Support (BLS) - AHA American Heart Association Upon Hire preferred Or
• CRT-Basic Life Support (BLS) - ARC American Red Cross Upon Hire preferred

How Corewell Health cares for you

• Comprehensive benefits package to meet your financial, health, and work/life balance goals. Learn more here.

• 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 identi