Regulatory Clinical Research Associate — IRB/FDA

Eisenhower Medical Center; United States; On-site; USD 32,000 - 48,000; Part time

Job summary

Eisenhower Medical Center is seeking a Regulatory Affairs Specialist to develop and maintain clinical trial regulatory documents and protocols for IRB submission. You will ensure compliance with FDA, OHRP, HHS, Eisenhower IRB and sponsor requirements, acting as a resource for investigators and staff.

The role requires at least two years in clinical trials or regulatory work, a bachelor’s degree in healthcare, and GCP/HSR training within 30 days.

Qualifications

• Requires a bachelor’s degree in healthcare or related field and completion of GCP training with HSR course within 30 days of hire.
• Two years of experience with clinical trials or related regulatory work are required.
• Preferred certifications include ACRP CCRC or SOCRA CCRP; certification upon eligibility is expected.

Responsibilities

• Demonstrates compliance with Code of Conduct and compliance policies and reports suspected violations.
• Performs pre-investigation, initiation and routine monitoring to ensure protocol, obligations, and regulations are followed.
• Monitors subject records for quality, data integrity and SOP compliance.
• Prepares materials for IRB presentations; serves as a resource for the PI.
• Manages submissions of new studies, modifications, renewals, AE/SAE reports to IRB, FDA and sponsors.
• Guides protocols through regulatory committee processes to activation.
• Liaises with sponsors and regulatory agencies, coordinates communications with NCTN groups and sponsors.
• Creates training materials and staff training on protocol updates.
• Disseminates new protocol information to study teams.
• Updates model informed consent language to local context.
• Maintains multi-level research network communications with DOTs, IRB, FDA and sponsors.
• Maintains standard regulatory files and documentation packages.
• Occasionally works evenings and weekends as needed.
• Performs other duties as assigned.

Skills

Regulatory compliance

IRB liaison

Documentation control

Communication skills

Confidentiality

Education

Bachelor’s degree in healthcare or related field

Master’s degree preferred

Tools

CITI Program GCP

IRB submission tools

Job description

Eisenhower Medical Center is seeking a Regulatory Affairs Specialist to develop and maintain clinical trial regulatory documents and protocols for IRB submission. You will ensure compliance with FDA, OHRP, HHS, Eisenhower IRB and sponsor requirements, acting as a resource for investigators and staff.

The role requires at least two years in clinical trials or regulatory work, a bachelor’s degree in healthcare, and GCP/HSR training within 30 days.