Part time, day position

General Summary:

The Clinical Research Coordinator II (CRC II) position in the Surgical Clinical Trials office 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.

Essential Duties:

1. 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.

2. 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.

3. Review and process requests for approval of research protocols submitted to the IRB. Review research consent to determine consistency with guidelines.

4. Communicate effectively with subjects, key research personnel, IRB, ancillary staff, study sponsors, and primary care providers in accordance with Beaumont hospitality standards.

5. Prepare for and participate in sponsor and external regulatory audits and departmental audits, including review of study and regulatory documents for accuracy and completeness.

6. Patient/Family interaction - utilizes effective communication skills, incorporate specific age, cultural, or developmental needs.

7. Maintain technical and professional expertise.

Standard Requirements:

A. Education / Training: 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 required.

B. Work Experience: Must have good working knowledge of all applicable FDA guidelines and Good Clinical Practices.

C. Certification, Licensure, Registration: National Research Certification (SoCRA or ACRP) required. BLS Certification required.

D. Other Qualifications: Excellent database and computer skills. Microsoft Word, Excel, HDS, Outlook. Excellent verbal and written skills and organizational skills required. Must be able to assume responsibility, work autonomously, meet deadlines and maintain confidentiality.

Preferred Qualifications: Phlebotomy skills prior to hire highly preferred.

ACKNOWLEDGEMENT OF EMPLOYMENT UNDER RESEARCH GRANT