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
Study Trial Master File oversight, review and filing
Organise study related meetings including but not limited to preparation of agenda/ minute taking and maintenance of risk/ issue/ decision logs
May perform applicable site monitoring / co-monitoring visits (ad hoc, pre-study, initiation, routine monitoring close-out visits)
Provides rapid action to address both internal and site QA findings from audits
May manage, coordinate, and oversee the activities from third party vendors including deliverables metrics, accruals, process planning, and implementation
General study tracking and maintenance and study site oversight including but not limited to site performance, metrics, monitoring report review, etc.
Assist and support study data related activities including data review, query creation and resolution, study and protocol deviation reviews, safety reviews, etc.
Routinely support and participate in department and clinical trial team meetings and participate in collaborative efforts (e.g., protocol development, CRO selection, departmental initiatives, etc.)
Review and verification of contracted vendor activities including vendor invoice review

Bachelor’s, nursing degree or equivalent required, science preferred
At least 2 years of experience (3 yrs 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
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

Associate Clinical Operations Leader – Clinical Trial Specialist

Key skills