General Summary:The Clinical Research Coordinator I (CRC I) position can function as study personnel and/or regulatory staff within a Biorepository. The CRC I study personnel is responsible for coordinating appropriate research studies, including subject recruitment, collecting biological specimens, follow up, data management and basic laboratory specimen handling and processing.Job Duties: 1. The CRC I communicates with study sponsors, research team and the Institutional Review Board. Assists with basic regulatory document preparation e.g. Amendments, AE reporting to IRB, assessment and reporting of protocol deviations with oversight.2. Participates in research subject screening, recruitment and enrollment. Consent and conduct research visits for data collection/no risk trials or no study article/minimal risk trials with oversight. Responsible for collecting, processing and shipping of research specimens, with appropriate and specific training.3. Documents study related information in case report forms or electronic data capture systems, handles data queries and participates in monitoring visits. Obtain, review and maintain source documents.4. Maintains organization of all trial related documents and correspondence. Implement quality control and assurance methods.5. Practice BH hospitality standards. Maintain professional and technical knowledge.6. Subject/Family Communication, protect patient confidentiality.STANDARD QUALIFICATIONS A. Education / Training: Bachelor’s degree in health related field with two to five years relevant clinical experience OR two to five years research experience with National Research Certification (SoCRA or ACRP). Phlebotomy skills strongly preferred. If applicable, department-specific certification and/or experience may also be required.B. Work Experience: 2-5 years relative clinical research experience. Laboratory experience highly preferred.C. Certification, Licensure, Registration: National Certification (SoCRA or ACRP) required at time of hire if lack of bachelor’s degree (per Education/Training requirements section above). BLS Certification required.D. Other Qualifications: Expert database and computer skills: Microsoft Office (Word, Excel), Outlook, HDS, excellent verbal and written communication skills, ability to work independently and assume responsibility, excellent organizational skills, ability to meet data deadlines and maintain confidentiality. Maintain data integrity within the department. Must be able to work in a team consisting of physicians, nurses, technicians, secretarial staff and ancillary hospital staff. Knowledge of FDA Regulations and Good Clinical Practices.Preferred Qualifications: Phlebotomy skills strongly preferred.ACKNOWLEDGEMENT OF EMPLOYMENT UNDER RESEARCH GRANT Beaumont Health is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, gender identity, sexual orientation, age, status as a protected veteran, or status as a qualified individual with a disability.
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