Job Description

Systimmune Inc. is a clinical-stage biopharmaceutical company located in Redmond, WA. 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 several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, Systimmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.

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.

Essential Duties and 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.
  
   

Required Skills & 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.

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 discovery or 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 offers a comprehensive benefits package. 

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

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