Full time (40 hour, 5 days) Clinical Research Associates (in-house) are needed in Basking Ridge, NJ office to

• Monitor early phase oncology trials, and manage adverse events with good knowledge of Antibody Drug Conjugate (ADC) drug mechanism and toxicity.
• Monitor study protocol compliance through site co-monitoring visits, and oversee source data verification in accordance with the Standard Operating Procedure (SOPs) and Clinical Monitoring Plan.
• Oversee and manage site study activities, progress and vendor Clinical Research Organization (CROs).
• Manage and maintain essential research and study documentation in electronic Trial Master File (eTMF) in compliance with Good Clinical Practice (GCP) and FDA requirements.
• Conduct data review and cleaning activities to identify and address data quality issue.
• Manage study lab and study drug supplies and perform drug accountability review.

Position requires Master’s or equivalent in Pharmacy, Biomedical Engineering, or closely related field; Have Certificate of Good Clinical Practice (GCP); with minimum 18 months’ clinical trial experience in pharmaceuticals industry with all of the following: oncology trials development and monitoring, clinical trial management, research documents maintenance via eTMF.

Send resumes to Sr. HR Manager, Attn: Ruffy Chen, DUALITYBIO INC, ruffy.chen@dualitybiologics.com