Clinical Research Associate-Regulatory

Eisenhower Health • Rancho Mirage, CA

85d • $22 - $34

About The Position

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. Specialties actively engaged in clinical research include Oncology, HIV, Infectious Disease, Gastroenterology, Cardiology, Orthopedics and Pulmonology.

Requirements

• Bachelor’s degree in healthcare and/or related field.
• Completion of CITIProgram.org Good Clinical Practice (GCP) Course and Human Subjects Research (HSR) course within thirty (30) days of hire.
• Two (2) years of experience with clinical trials or related regulatory experience.

Nice To Haves

• Master’s degree.
• ACRP CCRC or SOCRA CCRP Certification; certification required upon eligibility.
• Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.
• Experience developing and maintaining record management systems.
• Experience preparing various forms, documents and reports.

Responsibilities

• Demonstrates compliance with Code of Conduct and compliance policies, and takes action to resolve compliance questions or concerns and report suspected violations.
• Performs pre-investigation, initiation and routine monitoring to assure that the protocol, obligations, responsibilities, and regulations are established and followed.
• Monitors subject records for quality, data integrity, and compliance with regulations and organization’s standard operating procedures (SOPs).
• Prepares materials for Institutional Review Board (IRB) presentation; serves as a resource for the PI.
• Independently manages and prepares submissions of new studies, modifications, renewals, adverse events, and study closures to the IRB, FDA and sponsors.
• Shepherds protocols through the regulatory committee process in a timely manner to ensure activation of trial and for all regulatory aspects of the protocols assigned.
• Serves as the liaison to sponsors, governing agencies and facilitates transmission of verbal and written communication to sponsors.
• Creates training documents and documents staff training based on updates to research protocols.
• Distributes new protocol information to study team members.
• Updates model informed consent document from sponsor with local context (boilerplate) language.
• Maintains communication with all elements of a multi-level research network.
• Maintains standard regulatory files (electronic and hard copy) including various documentation related to clinical trials.
• Works occasional evenings and weekends as needed.
• Performs other duties as assigned.

What This Job Offers

• Job Type: Part-time
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees