SystImmune · 3 weeks ago
Clinical Trial Assistant
Princeton, NJ, US
Full-time
Onsite
Entry Level
$60K/yr - $90K/yr
2+ years expSystImmune is a leading and well-funded clinical-stage biopharmaceutical company specializing in developing innovative cancer treatments. They are seeking a Clinical Trial Assistant to support day-to-day operations of clinical studies, ensuring compliance with protocols and regulatory requirements while assisting the Clinical Project Management team.
BiopharmaBiotechnologyProfessional Services
Responsibilities
Develop and distribute meeting agendas, minutes and monthly status reports to document key project updates and communications to relevant stakeholders, as requested
Participate in regular team meeting / teleconferences; CRO, Vendor and Investigator Site meetings as necessary; and Investigator Meetings, as necessary
Support Clinical Project Management team in communication to CRO, Vendors and Investigator Sites
Support the Clinical Project Management team with study start-up activities, to include preparing and/or reviewing study-related documents (e.g., Monitoring Plan, Laboratory Manual, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines, study logs and forms Site Contracts and Budgets, Vendor Contracts and Budgets, etc.)
Support the Clinical Project Management team in the tracking of subject recruitment at all study sites; monitoring visits and approval; infringements, breaches, and misconduct, fraud, and negative trends and protocol deviations. Notify CRO and sites of updates on global study information
Assist Clinical Project Management team in the collection, review and filing of site Essential Documents, and maintenance of the TMF
Assist in the tracking of clinical supplies at site in coordination with established systems such as IWRS, EDC and CTMS as needed
Support the Clinical Project Management team in formal risk assessment activities; review and corrective action plans across study, participates in the planning of quality assurance activities, internal and external audits/inspections, and coordinates communication of audit/inspection findings
Communication and support Clinical Project Management team with cross-functional study team interaction
Perform other duties as assigned
Qualification
Required
Bachelor's degree in health science or related field
Excellent verbal and written communication skills required
Excellent organizational, multi-tasking and time management skills required
Working knowledge of International Conference on Harmonization Good Clinical Practice guidelines
Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF)
Located in NJ or can commute to Princeton, NJ
Ability to travel as required
Preferred
2 years in research experience preferred
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
Company
SystImmune
SystImmune is a biotechnology company.
51-200 employees
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 StageLeadership Team
Martin S. Olivo, MD, MSc,
Chief Medical Officer
Recent News
Company data provided by crunchbase