SystImmune · 1 day ago
Clinical Research Associate
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company specializing in developing innovative cancer treatments. The Clinical Research Associate (CRA) will assist in site monitoring activities for early-phase oncology clinical trials, ensuring compliance with protocols and regulatory requirements while collaborating with senior team members.
BiopharmaBiotechnologyProfessional Services
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
Qualification
Required
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%)
Preferred
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
Benefits
100% paid employee premiums for medical/dental/vision
STD
LTD
401(k) plan with a 50% company match of up to 3%
Vesting schedule of only 5 years
15 PTO days per year
Sick leave
11 paid holidays
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Company
SystImmune
SystImmune is a biotechnology company.
H1B Sponsorship
SystImmune has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2023 (1)
2022 (2)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageRecent News
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