Hoag Health System
CLINICAL RESEARCH COORDINATOR (RN) - MOLECULAR IMAGING AND THERAPY
Hoag Health System, Newport Beach, California, us, 92659
CLINICAL RESEARCH COORDINATOR (RN) - MOLECULAR IMAGING AND THERAPY
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CLINICAL RESEARCH COORDINATOR (RN) - MOLECULAR IMAGING AND THERAPY
role at
Hoag Health System
Primary Duties and Responsibilities The Clinical Research Coordinator RN is responsible for all aspects of clinical research activities and works in close cooperation with study physicians. The CRC‑RN provides support, coordination and leadership for FDA‑regulated research including drug/device/biologic studies that may involve industry‑sponsored Phase I, II, III and IV clinical trials, government‑funded clinical research and investigator‑initiated clinical research. The CRC‑RN ensures a smooth, accurate process of clinical studies from the planning and approval stages through study completion and post‑study closure. This position reports to the Director of Clinical Research and works as a team member to support the growth and vision of the Hoag Institute for Research and Education.
The CRC‑RN is involved in all aspects of research studies from protocol review, preparation and administration of the informed consent, study submission to the Institutional Review Board, subject recruitment, accurate data collection and completion of case report forms (CRFs), adverse event reporting, scheduled subject follow‑up, and maintenance of regulatory binders. The CRC‑RN discusses research studies with potential subjects, obtains informed consent, schedules follow‑up visits, assists in budgeting and tracking study funds, submits CRFs and other data to the sponsor, participates in monitoring, auditing and close‑out visits, and maintains knowledge of GCP, human subjects protection and FDA regulatory guidelines.
Qualifications
One year of Clinical Research Coordinator experience or at least three years of experience in the specific medical specialty of the position
Patient coordination experience in a complex clinical trial setting
Medical terminology knowledge
Working knowledge of FDA, NIH and OHRP regulatory requirements and ICH GCP guidelines
Understanding of clinical trial methodologies and experience filing Institutional Review Board documents
Bachelor of Science in Nursing (BSN) preferred
Familiarity with neurosciences, particularly stroke, epilepsy, movement disorders and cognitive disease preferred
License Required Current licensure in good standing as a Registered Nurse in the State of California.
Certifications Preferred
Certified Clinical Research Coordinator certificate (ACRP or SoCRA), or completion within two years of hire
Maintain CPR, BLS, ACLS, NALS, PALS, E.P. certifications as applicable per hospital policy
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CLINICAL RESEARCH COORDINATOR (RN) - MOLECULAR IMAGING AND THERAPY
role at
Hoag Health System
Primary Duties and Responsibilities The Clinical Research Coordinator RN is responsible for all aspects of clinical research activities and works in close cooperation with study physicians. The CRC‑RN provides support, coordination and leadership for FDA‑regulated research including drug/device/biologic studies that may involve industry‑sponsored Phase I, II, III and IV clinical trials, government‑funded clinical research and investigator‑initiated clinical research. The CRC‑RN ensures a smooth, accurate process of clinical studies from the planning and approval stages through study completion and post‑study closure. This position reports to the Director of Clinical Research and works as a team member to support the growth and vision of the Hoag Institute for Research and Education.
The CRC‑RN is involved in all aspects of research studies from protocol review, preparation and administration of the informed consent, study submission to the Institutional Review Board, subject recruitment, accurate data collection and completion of case report forms (CRFs), adverse event reporting, scheduled subject follow‑up, and maintenance of regulatory binders. The CRC‑RN discusses research studies with potential subjects, obtains informed consent, schedules follow‑up visits, assists in budgeting and tracking study funds, submits CRFs and other data to the sponsor, participates in monitoring, auditing and close‑out visits, and maintains knowledge of GCP, human subjects protection and FDA regulatory guidelines.
Qualifications
One year of Clinical Research Coordinator experience or at least three years of experience in the specific medical specialty of the position
Patient coordination experience in a complex clinical trial setting
Medical terminology knowledge
Working knowledge of FDA, NIH and OHRP regulatory requirements and ICH GCP guidelines
Understanding of clinical trial methodologies and experience filing Institutional Review Board documents
Bachelor of Science in Nursing (BSN) preferred
Familiarity with neurosciences, particularly stroke, epilepsy, movement disorders and cognitive disease preferred
License Required Current licensure in good standing as a Registered Nurse in the State of California.
Certifications Preferred
Certified Clinical Research Coordinator certificate (ACRP or SoCRA), or completion within two years of hire
Maintain CPR, BLS, ACLS, NALS, PALS, E.P. certifications as applicable per hospital policy
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