Clinical Research Associate Trainer

Systimmune • Princeton, NJ

1d • $120,000 - $160,000

About The Position

The CRA Trainer will play a critical role in developing and delivering global training programs for Clinical Research Associates (CRAs) both Internal and functional service providers (FSPs) to ensure compliance with ICH-GCP guidelines, local regulations, and company SOPs. This position requires a highly organized, proactive individual with deep clinical research experience and a passion for mentoring and education. The CRA Trainer will collaborate with Clinical Operations leadership to standardize best practices and enhance CRA performance across all phases of clinical trials.

Requirements

• Bachelor’s degree in health sciences or related field.
• Experience as a line manager of CRAs and a minimum of 10 years of experience as a CRA, preferred strong oncology trial expertise.
• Proven ability to conduct and oversee monitoring visits (site evaluation, initiation, interim, close-out) as well as identify gaps with mitigation strategies to address.
• Excellent verbal and written communication skills; strong presentation and facilitation abilities.
• In-depth knowledge of ICH-GCP guidelines and clinical trial processes.
• Critical thinking for troubleshooting monitoring challenges
• Proficiency in Microsoft Office Suite and clinical trial systems (CTMS, EDC, eTMF, IRT and ePRO).
• Strong organizational and time management skills; ability to manage multiple priorities.
• Experience in developing training materials and delivering educational programs preferred.
• Ability to travel as needed (up to 25%).

Responsibilities

• Design, develop, and implement comprehensive CRA training programs (onboarding and ongoing education).
• Create training materials, including manuals, SOP guides, and learning modules aligned with regulatory and company standards.
• Conduct live and virtual training sessions on monitoring practices, site management, and protocol compliance.
• Mentor CRAs on effective site relationship management, patient recruitment strategies, and data quality oversight.
• Provide guidance on clinical trial systems (CTMS, EDC, eTMF, IRT, ePRO, etc.) and investigational product accountability.
• Assess CRA competency through evaluations, feedback sessions, performance metrics, co-monitoring and monitoring report review as needed.
• Collaborate with the Clinical Project Managers within Clinical Operations to identify training gaps and develop targeted solutions.
• Stay current with regulatory updates and industry best practices to ensure training content remains relevant.
• Support development of study-specific training for CRAs and site personnel.
• Maintain documentation of all training activities for audit readiness.

Benefits

• SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees