Clinical Trials Specialist (In-house CRA)

Actalent - Tarrytown, NY

Full-time - Mid Level

Hybrid - Tarrytown, NY

10,001+ employees

Administrative and Support Services

About the position

The Clinical Trials Specialist will support Clinical Study Leads in executing global clinical trials, managing both internally sourced studies and those outsourced to CROs. This role involves coordinating meetings, preparing materials, and maintaining study documentation, while also overseeing site activation and enrollment processes.

Responsibilities

• Support Clinical Study Leads in the execution of global clinical trials.
• Schedule and coordinate meetings for clinical study teams.
• Prepare agendas, presentation materials, and minutes for meetings.
• Collate data for feasibility and site selection assessments.
• Review site usability databases and study documents such as informed consent forms and case report forms.
• Compile and maintain study manuals and manage the eTMF.
• Track site activation and enrollment, and monitor investigator/site status.
• Support clinical trial registry postings.
• Manage or oversee Third Party Vendors as needed.
• Participate in SOP revisions or departmental initiatives.

Requirements

• 3+ years of clinical trials experience.
• 2+ years of managing Trial Master File.
• 2+ years of experience supporting CTMs on CRO management.
• 2+ years of experience taking meeting minutes.