Clinical Research Associate II

🕒 5 days ago

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SystImmune

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

💰 $50M Series B - Syntimmune on 2017-06

Biotechnology • Pharmaceuticals • Healthcare

SystImmune is a clinical-stage biotechnology company focused on discovering and developing antibody-based cancer therapies. It uses proprietary technology platforms (AIDP — AI-powered drug discovery, HIRE ADC — an ADC platform, GNC — multi-specific antibody discovery/engineering, and SEBA — bispecific antibody platform) to design ADCs, bispecific antibodies, peptides and protein therapeutics and to advance candidates from discovery through preclinical and clinical development to commercialization. Public information highlights a robust oncology pipeline (including izalontamab brengitecan / Iza‑bren with regulatory approvals in China and breakthrough therapy designation from the U. S. FDA), multiple clinical data presentations, and a collaboration with Bristol Myers Squibb.

📋 Description

• 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) • 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 • 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.

🎯 Requirements

• Bachelor’s degree in health science or related field • 2+ years monitoring Oncology trials independently • Excellent verbal and written communication skills required • Excellent organizational, multi-tasking and time management skills required • Demonstrated experience developing/maintaining site relationships and securing compliance • 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) • Ability to travel as required (50-75%)

🏖️ Benefits

• Health insurance • 401(k) matching • Paid time off • Flexible work arrangements