Beaumont Health System Clinical Research Nurse Sr. Monitor in Royal Oak, Michigan
Clinical Research Nurse Sr. - MonitorReq #: 30127914 Category: Nursing Facility: Research Building Department: RADM CONLEJ 90040 RIEduc Schedule: Full time Shift: DaysHours: 8 am - 4:30 pm; Days and Hours may vary as needed Job Details:General Summary:The Clinical Research Nurse Sr. - Monitor provides monitoring of clinical research studies, ensuring compliance with research protocol, proper conduct, proper recordkeeping and adherence to FDA/ICH/HIPPA regulations and Research Institute Policies/SOPs. The Clinical Research Nurse Sr. - Monitor promotes good clinical practices in the conduct of clinical investigations by possessing knowledge of federal regulations and guidance documents for the conduct of clinical trials and human participation protection.Essential Duties:The Clinical Research Nurse Sr.- Monitor prepare and conducts audits and monitoring across departments; prepares reports and process improvement strategies in collaboration with the Process Improvement Manager and research team; reports deficiencies to the Process Improvement Manager, Research Directors, IRB and RI Compliance Committee.Maintains professional growth and development, including current knowledge of clinical research best practices, Department of Health and Human Services (HHS), International Commission on Harmonization (ICH-GCP) and Food and Drug Administration (FDA) Code of Federal Regulations relating to the conduct of clinical research.Communicates effectively with research teams, principal investigators, ancillary staff and research oversight committees (IRB, RICC) to ensure protocol adherence, participant safety and regulatory compliance. Mentor, train and review work of clinical research staff.Participate in providing educational experiences and provides training regarding research conduct to research and non-research staff.Standard Qualifications:Education / Training: BSN required. 3 to 5 years of clinical research experience required;For current Beaumont employees; three (3) years must be Beaumont clinical research experience.Certification, Licensure, Registration: MI Registered Nurse license.National research certification (SoCRA or ACRP) required. BLS Healthcare Provider Certification required.Work Experience: Evidence of steady growth in clinical research proficiency required, including regulatory submissions, budget development, project feasibility assessment, project lead, training/mentoring junior research staff. MS Word, Excel, Epic, Reveal, Outlook proficiency required.Other Qualifications: Expert clinical skills, advanced clinical research skills, critical thinking and ability to integrate knowledge of regulatory, ethical and scientific aspects of clinical research into practice. Good working knowledge of FDA Regulations and Good Clinical Practices. Excellent verbal and written communication skills required. Excellent writing and organizational skills required.Preferred Qualifications: Previous QA/Monitor highly preferred.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.