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SystImmune · 19 hours ago

Senior Clinical Research Associate

Princeton, NJ

Full-time

Hybrid

Senior Level

$90K/yr - $130K/yr

5+ years exp

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company specializing in developing innovative cancer treatments. The Senior Clinical Research Associate will manage and oversee clinical study sites to ensure data quality and patient safety in accordance with guidelines and regulations.

BiopharmaBiotechnologyProfessional Services

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, Safety Management Plan, etc.)

Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (i.e., study-site webinars, newsletters or other potential creative solutions)

Monitor recruitment, data quality and patient safety while 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, curricula vitae of investigators and study personnel, clinical investigators brochure, protocols, case report forms 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 reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP

Qualification

Oncology trial monitoringICH-GCP guidelinesClinical trial systemsBachelor’s degreeMulti-taskingSite relationship managementMicrosoft OfficeCommunicationOrganizational skillsTime management