Hoag Health System
Clinical Research Coordinator II (RN) : Cell Therapy Research
Hoag Health System, Newport Beach, California, us, 92659
Clinical Research Coordinator II (RN) : Cell Therapy Research
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Clinical Research Coordinator II (RN) : Cell Therapy Research
role at
Hoag Health System . Responsibilities
The Clinical Research Coordinator RN is responsible for all aspects of clinical research activities. They provide support, coordination and leadership for FDA regulated research including drug/device/biologic studies in industry-sponsored Phase I‑IV clinical trials, government funded research and investigator‑initiated studies. They ensure smooth, accurate process of clinical studies from planning and approval through study completion and post‑study closure. They support protocol review, informed consent, Institutional Review Board submission, subject recruitment, accurate data collection, adverse event reporting, scheduled subject follow‑up and maintenance of regulatory binders. They assist with sponsor data submission, monitoring, auditing and close‑out visits. Qualifications
Education and Experience 3‑4 years 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 required. Medical terminology required. 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. Familiar with the medical area of neurosciences particularly in 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 Hold current Certified Clinical Research Coordinator certificate (ACRP or SoCRA), or complete within two years of hire. Maintain CPR, certifications (BLS, ACLS, NALS, PALS, E.P., etc.) as applicable per hospital policy. About Hoag
Hoag Memorial Hospital Presbyterian is a nonprofit regional health care delivery network in Orange County, California, consisting of three acute‑care hospitals with sixteen urgent care centers, eleven health centers and a network of more than 1,800 physicians. Hoag offers a comprehensive blend of health care services including six institutes providing specialized care in the areas of cancer, heart and vascular, neurosciences, women's health, orthopedics, and digestive health. Hoag is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Hoag is committed to the principle of equal employment opportunity for all employees and providing employees with a work environment free of discrimination and harassment. Hoag hires a diverse group of people in a manner that allows them to reach their full potential in the pursuit of organizational objectives.
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Join to apply for the
Clinical Research Coordinator II (RN) : Cell Therapy Research
role at
Hoag Health System . Responsibilities
The Clinical Research Coordinator RN is responsible for all aspects of clinical research activities. They provide support, coordination and leadership for FDA regulated research including drug/device/biologic studies in industry-sponsored Phase I‑IV clinical trials, government funded research and investigator‑initiated studies. They ensure smooth, accurate process of clinical studies from planning and approval through study completion and post‑study closure. They support protocol review, informed consent, Institutional Review Board submission, subject recruitment, accurate data collection, adverse event reporting, scheduled subject follow‑up and maintenance of regulatory binders. They assist with sponsor data submission, monitoring, auditing and close‑out visits. Qualifications
Education and Experience 3‑4 years 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 required. Medical terminology required. 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. Familiar with the medical area of neurosciences particularly in 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 Hold current Certified Clinical Research Coordinator certificate (ACRP or SoCRA), or complete within two years of hire. Maintain CPR, certifications (BLS, ACLS, NALS, PALS, E.P., etc.) as applicable per hospital policy. About Hoag
Hoag Memorial Hospital Presbyterian is a nonprofit regional health care delivery network in Orange County, California, consisting of three acute‑care hospitals with sixteen urgent care centers, eleven health centers and a network of more than 1,800 physicians. Hoag offers a comprehensive blend of health care services including six institutes providing specialized care in the areas of cancer, heart and vascular, neurosciences, women's health, orthopedics, and digestive health. Hoag is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Hoag is committed to the principle of equal employment opportunity for all employees and providing employees with a work environment free of discrimination and harassment. Hoag hires a diverse group of people in a manner that allows them to reach their full potential in the pursuit of organizational objectives.
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