Clinical Research Associate-Regulatory jobs in United States
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Eisenhower Health · 3 months ago

Clinical Research Associate-Regulatory

Eisenhower Health is dedicated to advancing healthcare through clinical research, and they are seeking a Clinical Research Associate-Regulatory to support the development and maintenance of regulatory documents for clinical trials. This role involves preparing clinical trial protocols and ensuring compliance with various regulatory bodies to facilitate the approval process for clinical trials.

Health CareHospitalMedicalOutpatient CareRehabilitation

Responsibilities

Responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted by investigators within the Health System
Preparation and maintenance of clinical trial protocols and related regulatory documents for submission to the Eisenhower Human Research Protections Program (Eisenhower Medical Center's Institutional Review Board or IRB)
Acts as a resource to investigators and staff for interpretation and execution of complex clinical research regulations, policies and procedures concerning the conduct of clinical trials

Qualification

Regulatory document preparationClinical trial protocolsFDA regulationsClinical research regulationsCommunication skills

Required

Responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted by investigators within the Health System
Preparation and maintenance of clinical trial protocols and related regulatory documents for submission to the Eisenhower Human Research Protections Program (Eisenhower Medical Center's Institutional Review Board or IRB)
Acts as a resource to investigators and staff for interpretation and execution of complex clinical research regulations, policies and procedures concerning the conduct of clinical trials
Knowledge of regulations from the FDA, OHRP, HHS, Eisenhower IRB, and the Research department
Experience in clinical research specialties including Oncology, HIV, Infectious Disease, Gastroenterology, Cardiology, Orthopedics and Pulmonology

Company

Eisenhower Health

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Eisenhower Health provides full range of state-of-the-art diagnostic, treatment and emergency facilities.

Funding

Current Stage
Late Stage

Leadership Team

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Ken Wheat
Executive Vice President/COO
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Ann Mostofi
CNO, Vice President Patient Care Services
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