Clinical Trials Specialist

Actalent - Basking Ridge, NJ

Full-time - Entry Level

Basking Ridge, NJ

10,001+ employees

Administrative and Support Services

About the position

The Clinical Trials Specialist supports Clinical Study Leads in the overall execution of global clinical trials, which includes both internally sourced studies and those outsourced to Contract Research Organizations (CROs). This role is crucial in ensuring that clinical trials are conducted efficiently and effectively, adhering to regulatory standards and timelines. The Specialist is responsible for a variety of tasks that facilitate the smooth operation of clinical studies, including scheduling and coordinating meetings, preparing agendas, presentation materials, and minutes for clinical study team meetings. In addition to meeting coordination, the Clinical Trials Specialist plays a key role in data management. This includes collating data for feasibility assessments and site selection, reviewing site usability databases, and contributing to the review of essential study documents such as informed consent forms and case report forms. The Specialist will also compile and maintain study manuals, manage the electronic Trial Master File (eTMF), and track site activation, enrollment, and monitoring visits. Any issues or delays encountered during the trial process must be escalated promptly to ensure that the study remains on track. Additional responsibilities include monitoring the status of investigators and sites, supporting clinical trial registry postings, contributing to Blind Data Review Meetings, managing Third Party Vendors, and participating in Standard Operating Procedure (SOP) revisions or departmental initiatives. The role requires a strong attention to detail and the ability to manage multiple tasks simultaneously, making effective communication and organizational skills essential for success in this position.

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 assessments and site selection.
• Review site usability databases and contribute to study document reviews.
• Compile and maintain study manuals and manage the eTMF.
• Track site activation, enrollment, and monitoring visits.
• Escalate any issues or delays encountered during the trial process.
• Monitor investigator/site status and support clinical trial registry postings.
• Contribute to Blind Data Review Meetings and manage Third Party Vendors.
• Participate in SOP revisions or departmental initiatives.

Requirements

• Strong organizational skills.
• Attention to detail.
• Effective communication skills.
• Ability to manage multiple tasks.