Clinical Trials Specialist

$83,200 - $120,640/Yr

Actalent - Basking Ridge, NJ

Full-time - Mid Level

Basking Ridge, NJ

1,001-5,000 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 requirements and timelines. The Specialist is responsible for a variety of tasks that facilitate the smooth operation of clinical studies. These tasks include scheduling and coordinating meetings, preparing agendas, presentation materials, and minutes for clinical study team meetings. The Specialist plays a key role in collating data for feasibility assessments and site selection, which are critical steps in the planning phase of clinical trials. In addition to these responsibilities, the Clinical Trials Specialist reviews site usability databases and contributes to the review of essential study documents such as informed consent forms and case report forms. The Specialist will compile and maintain study manuals, manage the electronic Trial Master File (eTMF), and track site activation, enrollment, and monitoring visits. It is also the Specialist's responsibility to escalate any issues or delays that may arise during the trial process, ensuring that the study remains on track. Additional duties include monitoring investigator and site status, 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. This role requires a proactive approach to problem-solving and the ability to manage multiple tasks simultaneously, making strong organizational skills and attention to detail essential attributes 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 study documents such as informed consent forms and case report forms.
• Compile and maintain study manuals and manage the eTMF.
• Track site activation, enrollment, and monitoring visits.
• Escalate any issues or delays in 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

• Mid-level experience in clinical trials or related field.
• 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.