Clinical Trial Assistant

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Syst Immune 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 bispecific, multispecific antibodies, and antibody‑drug conjugates (ADCs). Syst Immune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications, as well as a robust preclinical pipeline of potential cancer therapeutics in the discovery and IND‑enabling stages.

About the role

The Clinical Trial Assistant supports day‑to‑day operations of Syst Immune clinical studies, assisting the clinical operations project team to facilitate the management of clinical trial processes including planning, execution, and closeout of outsourced clinical trials. The candidate ensures compliance with protocol, ICH GCP, applicable regulatory requirements, and SOPs.

• Develop and distribute meeting agendas, minutes and monthly status reports to document key project updates and communications to relevant stakeholders.
• Participate in regular team meetings / teleconferences, CRO, vendor and investigator site meetings, and investigator meetings as necessary.
• Support the Clinical Project Management team in communication with CROs, vendors and investigator sites.
• Prepare and/or review study‑related documents (e.g., Monitoring Plan, Laboratory Manual, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines, study logs, site contracts and budgets, vendor contracts and budgets, etc.) as part of study start‑up activities.
• Track subject recruitment at all study sites; monitor visits and approval; record infringements, breaches, misconduct, fraud, and protocol deviations; notify CRO and sites of updates on global study information.
• Collect, review and file site essential documents and maintain the TMF.
• Track clinical supplies at site in coordination with systems such as IWRS, EDC and CTMS.
• Participate in formal risk assessment activities; review corrective action plans; plan quality assurance activities; coordinate communication of audit/inspection findings.
• Communicate and support cross‑functional study team interactions.
• Perform other duties as assigned.

• Bachelor’s degree in health science or related field.
• 2 years of research experience preferred.
• Excellent verbal and written communication skills.
• Excellent organizational, multi‑tasking and time‑management skills.
• Working knowledge of ICH GCP guidelines.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (CTMS, EDC, eTMF).
• Located in NJ or able to commute to Princeton, NJ.
• Ability to travel as required.

The expected base salary range for this position is $60,000 – $90,000 annually, based on qualifications, experience and skills.

Benefits include 100% paid employee premiums for medical/dental/vision, STD, LTD, a 401(k) plan with a 50% company match up to 3% (vested after 5 years), 15 PTO days per year, sick leave, 11 paid holidays and additional benefits.

Location:

Princeton, NJ (commute from other parts of NJ accepted).

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