Senior Clinical Research Associate – Oncology

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🏖️ New Jersey, Washington – Remote

🏖️ New Jersey – Remote ☕ Washington – Remote

💵 $110k - $145k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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 and liaise with CRO teams, central labs, specialty labs and vendors • Ensure investigator sites meet contractual and regulatory requirements for site initiation and first release of study drug • Assist in developing study/program plans, including Monitoring Plans, eCRF Completion Guidelines, Data Management Plans and Safety Management Plans • Manage patient recruitment strategies and identify barriers while proposing solutions • Monitor recruitment, data quality and patient safety onsite and remotely through EDC systems and direct site communication • Liaise with site personnel to ensure timely and correct eCRF data entry and resolution of data queries • Maintain project files and investigator/site correspondence • Identify and follow up on SAEs at study sites • Assist with data listing, data coding, patient profile reviews, database lock and site close-out activities • Ensure timely submission of documents to the Trial Master File • Perform investigational product inventory and reconciliation and review storage and security • Verify investigational product dispensing and administration according to protocol • Verify issues or risks associated with blinded or randomized investigational product information

🎯 Requirements

• Bachelor’s degree in health science or related field • 5+ years monitoring Oncology trials independently conducting on-site & remote monitoring visits • Excellent verbal and written communication skills • Excellent organizational, multi-tasking and time management skills • Demonstrated experience developing/maintaining site relationships and securing compliance • Working knowledge of International Conference on Harmonization Good Clinical Practice guidelines • Experience with Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) • Experience with clinical trial systems (e.g., CTMS, EDC and eTMF) • Ability to travel as required (50-75%) • Ability to work independently and in a small team environment • Ability to multitask and adjust direction based on changing project/corporate priorities

🏖️ Benefits

• 100% paid employee premiums for medical/dental/vision • STD • LTD • 401(k) plan with a 50% company match of up to 3% • Vesting schedule of only 5 years • 15 PTO days per year • Sick leave • 11 paid holidays • Learning and growth opportunities

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