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Troy, MI; SITE - Troy Hospital - 44201 Dequindre Rd - Troy; Royal Oak, MI
Source: Corewell Health careers · View original posting
From Corewell Health's posting. “We” and “our” refer to the employer.
Royal Oak - Full time, day shift
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
Scope of Work
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.
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.
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
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