Customer Name: Pharmaceutical - FSP
KSN Requisition #28660297
Number of Positions: 1
Job Title: Clinical Trial Assistant
Service Line: Scientific
Work Location: 1700 E Saint Andrew Pl Santa Ana, CA 92705
Pay Rate: 24
Est. Start Date: 11/4/2019
Est. End Date: 11/4/2022
Shift/Hours: 40 hours a week
Job Description: Clinical Trial Assistant:
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.
Core Job Responsibilities " 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.
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:
" 0-2 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.
" Ability to problem-solve.
" Proficiency with MS Word, Excel and PowerPoint.
Need for FSP Pharmaceutical CTA opening in Santa Ana CA. Must work onsite.
Looking for at leaset some exposure to clinical trial experience as a tudy coordinators or project speclialst or even a research intern.
Please highlight the following bullets for experience when submitting:
- Total years of clinical research experience and within what titles
- Years/months expeirence working in clinical systems such as eTMF, EDC or CTMS
- Total years/month experience working with investigative sites and within what capacity
- Years/experience exposed to ophthalmology or optometry if any
- Highest degree earned
- *If no clinical experience on clinical trials previously - what experience do they have within clinical research that would make them a fit.....