Clinical Research Associate Trainer

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

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.

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.

Qualifications

• 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%).

Compensation and Benefits:
The expected base salary range for this position is $120,000 - $160,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.

SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. 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.

We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.