Sr. Clinical Research Associate

Senior Clinical Research Associate (CRA) 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 tumour and haematologic indications, together with a robust preclinical pipeline of potential cancer therapeutics in the discover and IND‑enabling stages, representing cutting‑edge biologics development. The Senior Clinical Research Associate (CRA) supports SystImmune’s clinical trials. The Sr. CRA is responsible for 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 organised 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, speciality labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites. Ensure 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 (e.g., monitoring plan, eCRF completion guidelines, data management plan, safety management plan, etc.). Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (e.g., study‑site webinars, newsletters or other potential creative solutions). Monitor recruitment, data quality and patient safety on site and remotely through EDC systems and direct site communication. Liaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries. Maintain project files including ethics committee approvals, CVs of investigators and study personnel, clinical investigators brochure, protocols, case report form instructions, consent documents, clinical‑trial material shipping orders, start‑up meeting attendance documentation, letters of agreement, lab reference ranges and all investigator and site correspondence. Identify and complete follow‑up of SAEs at study sites. Assist with data listing, data coding, patient profile reviews, database lock and site close‑out activities. Ensure appropriate and timely submission of documents to the trial master file. Perform investigational product (IP) inventory, reconciliation and review of storage and security. Verify that the IP has been dispensed and administered to subjects/patients according to the protocol and verify any issues or risks associated with blinded or randomised information related to IP. Qualifications Bachelor’s degree in health science or a related field. 5+ years of independent monitoring of oncology trials, conducting on‑site and remote monitoring visits. Excellent verbal and written communication skills. Excellent organisational, multi‑tasking and time‑management skills. Demonstrated experience developing and maintaining site relationships and ensuring compliance. Working knowledge of ICH‑GCP guidelines. Experience with Microsoft Office products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC, eTMF). Ability to travel as required (50‑75%). Compensation and Benefits Expected base salary range: $90,000 – $130,000 annually. Actual compensation will be based on a variety of factors, including but not limited to the candidate’s qualifications, experience and skills. 100% paid employee premiums for medical, dental and vision. Short‑term disability (STD). Long‑term disability (LTD). 401(k) plan with 50% company match up to 3% and vesting schedule of 5 years. 15 PTO days per year. Paid sick leave. 11 paid holidays. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply. #J-18808-Ljbffr Systimmune