Clinical Trial Assistant - ImmunoOncology
SystImmune
Summary
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.
Job description
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 in NJ or can commute to Princeton, NJ
- Ability to travel as required
Requirements
- 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 in NJ or can commute to Princeton, NJ
- Ability to travel as required
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Short-Term Disability Insurance
- Long-Term Disability Insurance
- 401(k) Plan
- Paid Time Off
- Sick Leave
- Paid Holidays
Company overview
SystImmune is a biotechnology company specializing in immune system research and therapeutic development. The company focuses on advancing innovative approaches to modulate and harness the immune system for treating various diseases. With a name suggesting systemic immune system targeting, SystImmune likely engages in research areas such as immunotherapy, autoimmune disorders, cancer immunology, and infectious disease treatments. The company operates at the intersection of immunology and biotechnology, developing novel therapeutic candidates that aim to address unmet medical needs through immune system modulation. SystImmune's research efforts contribute to the growing field of immunotherapies, which have revolutionized treatment approaches for cancer and other immune-related conditions. The company represents the cutting edge of biotechnology research focused on understanding and manipulating immune responses for therapeutic benefit.