Clinical Research Associate jobs in United States
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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
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H1B Sponsor Likelynote

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

Clinical trial experienceICH-GCP knowledgeOncology trials exposureRegulatory requirementsSite managementOrganizational skillsAttention to detailTeam collaboration

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
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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

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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 Stage

Leadership Team

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Martin S. Olivo, MD, MSc,
Chief Medical Officer
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Company data provided by crunchbase