Kelly is currently seeking a Clinical Trial Assistant for a long-term engagement with one of our Global Medical Device clients in Milpitas in the San Jose area.
This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
Provides administrative and organizational support for assigned clinical trials and sites in accordance with Good Clinical Practice (GCP), guidelines, standards, federal regulations, and SOPs. Close collaboration with other members within Clinical R&D. Effectively manages multiple clinical study activities to assure accurate and timely initiation, enrollment, conduct and completion for assigned clinical trials.
• Serving as internal support for all members of assigned teams. • Supporting investigative sites toward completion and appropriate submission of all required clinical trial documents prior to site initiation. • Supporting establishment and maintenance of the electronic Trial Master Files (eTMF) for assigned clinical trials. • Coordinating Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate. • Supporting overall progress of clinical trials by regularly attending clinical trial team meetings, reviewing team communications and sharing pertinent information with assigned investigative sites, as requested by the Study Manager, Lead CRAs, CRAs and other clinical trial team members. • Assist the study team with study startup procedures, including preparing site binders. • Assisting assigned clinical trial teams to ensure that each clinical trial maintains audit/inspection readiness at each site and internally throughout the duration of assigned clinical trials. • Ensuring all equipment/supplies provided to investigative sites is appropriately tracked and reported to Study Manager and/or Lead CRA during study startup, maintenance, and closeout. • May assist in creation of Purchase Orders and site payment requests.
Minimum education required for competent performance: BA/BS or equivalent years of experience required. Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance: • 2 years of clinical research experience. • Knowledge of ophthalmology highly desirable, but not required. • Ability to problem-solve. • Good communication via written, verbal and listening skills. • Ability to report to corporate offices for routine, daily work. • Ability to successfully manage multiple competing priorities and adapt quickly to changing priorities. • Proficiency with MS Word, Excel, and PowerPoint
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