Clinical Trial Assistant

SystImmune, Inc.; Princeton (NJ); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Premium health insurance

401(k) match

PTO 15 days

Sick leave

Holidays

Dental & Vision

Job summary

SystImmune in Princeton, NJ is seeking a Clinical Trial Assistant to support day-to-day clinical study operations. You will assist the clinical operations team to ensure trials run per protocol, ICH-GCP, and SOPs, including document management and site coordination.

Responsibilities include meeting preparation, recruitment tracking, TMF maintenance, and collaboration with CROs and investigator sites; some travel may be required. Based near Princeton, NJ.

Qualifications

• Bachelor's degree in health science or related field.
• 2 years in research experience preferred.
• Excellent verbal and written communication skills.
• Excellent organizational, multi-tasking and time management skills.
• Working knowledge of ICH GCP guidelines and clinical trial systems.

Responsibilities

• Develop and distribute meeting agendas, minutes and monthly status reports to document key project updates and communications.
• Participate in regular team meetings; CRO, Vendor and Investigator Site meetings as necessary.
• Support Clinical Project Management in communications to CROs, Vendors and Investigator Sites.
• Assist start-up activities and review study-related documents (e.g., SOPs, manuals, contracts).
• Track subject recruitment, visits, and protocol deviations across sites.
• Assist in collection, review and filing of essential TMF documents.
• Track clinical supplies at site with IWRS, EDC and CTMS as needed.
• Support risk assessment activities and coordinate audits/inspections.
• Facilitate cross-functional study team communication.
• Perform other duties as assigned.

Skills

Verbal and written communication

Organizational skills

Multi-tasking

Time management

Education

Bachelor7s degree in health science or related field

Tools

Word

Excel

PowerPoint

SharePoint

Teams

CTMS

EDC

eTMF

Job description

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.

SystImmune is seeking a high quality, ambitious and experienced Clinical Trial Assistant to support day-to-day operations of SystImmune clinical studies. Assisting and providing support to the members of the clinical operations project team to facilitate the management clinical trial processes including planning, execution, and closeout of outsourced clinical trials. You will ensure that the trial is conducted in compliance with the protocol, ICH good clinical practice, applicable regulatory requirements, and applicable standard operating procedure work instructions.

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.

Qualifications:

• Bachelor’s degree in health science or related field.
• 2 years in research experience preferred.
• 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 inNJ or can commute to Princeton, NJ
• Ability to travel as required.

Compensation and Benefits:

The expected base salary range for this position is $60,000 - $90,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills. While most offers typically fall within the low to mid‑point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.

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.

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