Clinical Research Associate-Regulatory

Job title: 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. A key focus is the preparation and maintenance of clinical trial protocols and related regulatory documents for submission to Eisenhower Medical Center's Institutional Review Board (IRB) to obtain approval for 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 FDA, OHRP, HHS, Eisenhower IRB, and the Research department. Specialties actively engaged in clinical research include Oncology, HIV, Infectious Disease, Gastroenterology, Cardiology, Orthopedics and Pulmonology.

What You'll Do

• Develop and maintain regulatory documents for clinical trials and ensure trial readiness.
• Prepare and maintain clinical trial protocols and related regulatory submissions for Eisenhower Medical Center's IRB approvals.
• Serve as a resource to investigators and staff on interpretation and execution of complex clinical research regulations (FDA, OHRP, HHS, IRB, and the Research department).
• Collaborate with investigators' teams to ensure regulatory compliance across study activities and specialties (Oncology, HIV, Infectious Disease, Gastroenterology, Cardiology, Orthopedics, Pulmonology).
• Maintain document control systems and ensure accuracy, confidentiality and timely retrieval of study records.

What We're Looking For

• Education: Bachelor's degree in healthcare and/or related field; completion of CITI Program.org Good Clinical Practice (GCP) and Human Subjects Research (HSR) course within thirty (30) days of hire
• Licensure/Certification: Preferred: ACRP CCRC or SOCRA CCRP; certification required upon eligibility
• Experience: Required: Two (2) years of experience with clinical trials or related regulatory experience; Preferred: Experience with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines; experience developing and maintaining record management systems; experience preparing various forms, documents and reports

Nice to Have

• Master’s degree (preferred) and advanced certifications; familiarity with the specialties involved: Oncology, HIV, Infectious Disease, Gastroenterology, Cardiology, Orthopedics and Pulmonology

Compensation & Benefits

• Salary range: $22.83 - $34.51 per hour
• Schedule: Part-time, 24 hours per week
• Benefits: Not specified