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 Senior Clinical Research Associate (CRA) to support SystImmune’s clinical trials. The Sr. CRA is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs. The Sr CRA must be self-motivated, independent, and able to work in a small team environment. The successful candidate will be a highly organized individual who can also multitask and adjust direction based on changing project/corporate priorities. Responsibilities Perform Site Evaluation Visits, Site Initiation Visits, Interim monitoring visits and Close Out Visits. Prepare the study reference manual, including liaising with the Contract Research Organization (CRO) team (i.e., central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites. Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug. Assist in the development of study/program plans (i.e., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan,
