Support Phase 1, 2, 3 and 4 clinical studies with guidance
Support activities related to study/site feasibility, start-up, maintenance, and close-out
Manage study and site essential document review, collection, tracking, etc. from study start-up through maintenance and close-out
With guidance, support the Study Lead (CTM, AD, etc.) to prepare and maintain study documents and manuals as applicable (including but not limited Informed Consent Forms, study manuals, site materials, training materials, pharmacy, and laboratory related manuals, etc.)
Study Trial Master File (TMF) oversight
Ensure required study documents received, reviewed, and filed in the TMF in accordance with SOPs, GCP and applicable regulations
Organize study related meetings including but not limited to preparation of agenda/minute taking and maintenance of risk/issue/decision logs
May lead and present at study related meetings
May perform applicable site monitoring / co-monitoring visits (ad hoc, pre-study, initiation, routine monitoring close-out visits)

M.S/M.A/Ph.D or B.A/B.S/nursing degree is essential
At least 3 years of experience (4yrs preferred) in clinical studies (Pharmaceutical Industry Experience Preferred)
Previous site monitoring or study coordinator experience is preferred
Working knowledge of Good Clinical Practices (GCP) regulations and Standard Operating Procedures
Understanding of study phases and general knowledge of how they apply to clinical development
Demonstrated ability to work independently and in a team environment
Advanced knowledge of Word, Excel, and PowerPoint
Working knowledge of electronic Systems including Trial Master File, CTMS, etc. (e.g., Veeva Vault, Smartsheet, SharePoint, etc.)
Knowledge of the principles and practices of computer applications in database management
Strong verbal and written communication skills required
10%
20% travel may be required

Clinical Trial Specialist / Associate Clinical Trial Manager

Key skills