Senior Clinical Research Associate-Contractor

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company with locations in Redmond, WA and Princeton, NJ. The company specializes in developing innovative cancer therapies through its established drug development platforms, focusing on bi-specific antibodies, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune currently has multiple assets in clinical development across solid tumor and hematologic malignancies, supported by a robust preclinical pipeline advancing novel oncology therapeutics through discovery and IND-enabling stages.

Position Summary

SystImmune is seeking an experienced Senior Clinical Research Associate (CRA) Contractor to support the execution and oversight of clinical trials. The Senior CRA Contractor will be responsible for managing assigned clinical study sites to ensure patient safety, protocol compliance, and data integrity in accordance with ICH-GCP guidelines, applicable regulations, and study requirements. The ideal candidate is a highly organized, self-motivated clinical operations professional with strong oncology monitoring experience who can work independently while collaborating effectively with cross-functional teams and external vendors.

Responsibilities

Conduct Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs). Support site management activities to ensure compliance with protocol requirements, GCP, applicable regulations, and study timelines. Collaborate with CROs, central laboratories, specialty vendors, and internal stakeholders to support study execution and site readiness. Verify that investigator sites have completed all regulatory, contractual, and operational requirements prior to site activation and study drug release. Assist with development and review of study-related documents, including Monitoring Plans, eCRF Completion Guidelines, Data Management Plans, and Safety Management Plans. Monitor site enrollment activities and proactively identify and escalate recruitment challenges and mitigation strategies. Perform remote and on-site monitoring to assess patient safety, protocol compliance, source data verification, and data quality. Partner with site personnel to ensure timely and accurate data entry and prompt resolution of data queries. Maintain study documentation and ensure completeness of site regulatory files and essential documents. Identify, document, and follow up on Serious Adverse Events (SAEs) in accordance with study and regulatory requirements. Support database lock activities, data review, patient profile review, and site closeout activities as needed. Ensure timely submission and maintenance of essential documents within the Trial Master File (TMF/eTMF). Review investigational product accountability, storage conditions, reconciliation activities, and protocol compliance related to investigational product management. Escalate site issues, risks, and compliance concerns to study leadership in a timely manner.