Clinical Trial Assistant

Job description

Job responsibilities

• Coordinate and manage the ordering, shipping, labeling and tracking of study supplies (including investigational products) with limited supervision
• Establish, organize and maintain electronic study files and trial master files, with CRO as applicable, to ensure regulatory and protocol compliance including maintenance of study essential documentation (e.g.,…
• Contribute to operational excellence and continuous improvement
• Maintain, track and facilitate routing for approval and signature of clinical study documents including protocols, case report forms, Informed consents, Clinical trial agreements, non-disclosure agreements, etc
• Create purchase requests and process invoices
• Support clinical study manager with study budget tracking and payments of clinical sites and vendors
• Prepare and ship site binders and patient binders as necessary
• Collaborate with Clinical Study Managers (CSM) to develop clinical study informational materials such as newsletters, recruitment materials, etc

Job requirements

• Excellent communication, organization and interpersonal skills with strong attention to detail
• Strong ability to organize, prioritize and manage multiple priorities
• Prior experience in medical device clinical trials, regulatory support, clinical project coordination
• Proficient in MS Office suite, Adobe, video and web conferencing solutions
• Clinically savvy & good knowledge of basic medical terminology preferred
• Possess working knowledge of Good Clinical Practice as detailed in 21CFR and ISO 14155, and regulation such as 21 CFR Part 812
• Minimum of 2-4 years of related experience in clinical research with high school diploma or secondary education or equivalent
• Minimum Bachelor’s degree is a plus