Clinical Trial Assistant — Biotech Cancer Trials

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 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.