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SystImmune · 20 hours ago

Clinical Research Associate Trainer

Princeton, NJ

Full-time

Onsite

Senior Level, Lead/Staff

$120K/yr - $160K/yr

10+ years exp

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company specializing in developing innovative cancer treatments. The CRA Trainer will develop and deliver global training programs for Clinical Research Associates to ensure compliance with ICH-GCP guidelines and enhance CRA performance across clinical trials.

BiopharmaBiotechnologyProfessional Services

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

Qualification

Clinical trial expertiseICH-GCP guidelinesTraining program developmentMicrosoft Office SuiteClinical trial systemsCommunicationCritical thinkingOrganizational skillsTime managementPresentation skills

Required

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

Ability to travel as needed (up to 25%)