Actalent Clinical Trials Specialist in Tarrytown, New York
Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. Assigned to support the execution of one or more studies across a program. Support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).
Organizes and delivers reports and metrics
Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
Collates data for assessments such as feasibility and site selection and reviews site usability database
Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
Collates materials for training and investigator meetings
Tracks site activation, enrollment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
Ensures scheduled reports are received (i.e. 1572 re-portable changes, financial disclosure form)
Contributes to line listings review for Blind Data Review Meeting (BDRM)
Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
Additional Skills & Qualifications:
3+ Years of Clinical Trial Experience (Pharma/Biotech or CRO only)
2+ years of managing Trial Master File
2+ Experience supporting CTMs on CRO management
2+ years of Taking Meeting Minutes
Associate/Bachelors Degree minimum
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