Clinical Research Associate
About The Position
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. We are seeking a motivated Clinical Research Associate (CRA) to join our growing team supporting innovative early-phase oncology clinical trials (primarily Phase I). The CRA will assist in site monitoring activities and work closely with senior team members to ensure trial conduct is aligned with ICH-GCP, protocols, and regulatory requirements. This is an excellent opportunity for someone with CRA experience who is ready to take on broader site management responsibilities while being mentored by senior CRAs and clinical project managers.
Requirements
- Bachelor’s degree in health sciences or related field.
- 1-5 years of total clinical trial experience (e.g., as CRA, CTA, in-house CRA, or CRC).
- Exposure to oncology trials.
- Knowledge of ICH-GCP guidelines and regulatory requirements.
- Strong organizational skills, attention to detail, and ability to work both independently and within a team.
- Willingness to travel regionally (approx. 50%-75%).
Nice To Haves
- 1–5 years of experience in a CRA role, or at least 1 year in CRA role with 1-5 years in-house CRA, or Clinical Trial Assistant role.
- Someone who has supported Phase I or oncology studies or is eager to grow into that space with guidance.
- Strong foundational knowledge of GCP and site management but still gaining independence in full-site oversight.
Responsibilities
- Assist with site qualification, initiation, routine monitoring, and closeout visits Monitor patient safety, protocol adherence, and data integrity during on-site and remote visits.
- Perform source data review (SDR) and source data verification (SDV), ensuring timely resolution of data queries.
- Ensure investigator sites maintain compliance with GCP, protocol, and SOPs, and support inspection readiness efforts.
- Collaborate on the review and tracking of essential documents (e.g., ICFs, regulatory binders).
- Support cohort management activities (e.g., dose escalation, enrollment tracking) as assigned.
- Assist in documentation for Trial Master File (TMF) and site files to ensure completeness and accuracy.
- Provide site training and support for EDC and trial systems Contribute to patient recruitment and retention initiatives at the site level.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
11-50 employees
