Clinical Research Associate-Regulatory

About the role

Responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted by investigators within the Health System.

Key to this role is the 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) in order to obtain its approval for the clinical trials to proceed.

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, including those of the FDA, OHRP, HHS, Eisenhower IRB, and the Research department.

Responsibilities

• Prepare and maintain clinical trial protocols and related regulatory documents for submission to the Eisenhower IRB.
• Obtain approval for clinical trials from the Eisenhower IRB.
• Interpret and execute complex clinical research regulations, policies and procedures concerning the conduct of clinical trials.
• Provide guidance to investigators and staff on regulatory requirements and procedures.
• Ensure compliance with FDA, OHRP, HHS, Eisenhower IRB, and Research department guidelines.

Specialties

• Oncology
• HIV
• Infectious Disease
• Gastroenterology
• Cardiology
• Orthopedics
• Pulmonology