Unclassified - Tarrytown, NY
posted 2 months ago
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 smooth operation 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 role is pivotal in ensuring that all stakeholders are aligned and informed throughout the trial process. In addition to meeting coordination, the Clinical Trials Specialist is responsible for collating data 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 study manuals, manage the electronic Trial Master File (eTMF), and track site activation, enrollment, and monitoring visits. Any issues or delays encountered during these processes must be escalated promptly to ensure that the trials remain on schedule. The role further includes 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 position 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.