Clinical Trials Specialist at Actalent

Unclassified - Basking Ridge, NJ

Full-time - Entry Level

Basking Ridge, NJ

10,001+ employees

About the position

The Clinical Trials Specialist plays a crucial role in supporting Clinical Study Leads in the execution of global clinical trials. This position encompasses a variety of responsibilities that are essential for the successful management of both internally sourced studies and those outsourced to Contract Research Organizations (CROs). The Specialist is tasked with scheduling and coordinating meetings, which includes preparing agendas, presentation materials, and minutes for clinical study team meetings. This organizational aspect is vital for ensuring that all team members are aligned and informed about the progress and requirements of the clinical trials. In addition to meeting coordination, the Clinical Trials Specialist is responsible for collating data necessary for feasibility assessments and site selection. This involves reviewing site usability databases and contributing to the review of critical study documents, such as informed consent forms and case report forms. The Specialist will also compile and maintain comprehensive study manuals, manage the electronic Trial Master File (eTMF), and track site activation, enrollment, and monitoring visits. It is imperative for the Specialist to escalate any issues or delays that may arise during the trial process to ensure timely resolution. Further responsibilities include monitoring the status of investigators and sites, supporting clinical trial registry postings, and contributing to Blind Data Review Meetings. The Specialist will also manage relationships with Third Party Vendors and participate in revisions of Standard Operating Procedures (SOPs) or other departmental initiatives. This multifaceted role requires a blend of technical knowledge and soft skills, including strong organizational abilities, attention to detail, effective communication skills, and the capacity to manage multiple tasks simultaneously.

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 trials.
• 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 and departmental initiatives.

Requirements

• Strong organizational skills to manage multiple tasks effectively.
• Attention to detail to ensure accuracy in documentation and processes.
• Effective communication skills for collaboration with team members and stakeholders.