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 for feasibility assessments and site selection. This involves reviewing site usability databases to ensure that selected sites are appropriate for the studies being conducted. The Specialist also contributes to the review of critical study documents, such as informed consent forms and case report forms, ensuring that all documentation meets regulatory standards and is clear for participants. The role further includes compiling and maintaining study manuals, managing the electronic Trial Master File (eTMF), and tracking site activation, enrollment, and monitoring visits. The Specialist must be proactive in escalating any issues or delays that may arise during the trial process. Additional 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, ensuring that the clinical trials are conducted efficiently and in compliance with all regulations.
Responsibilities
- Support Clinical Study Leads in the execution of global clinical trials.
- Schedule and coordinate meetings, preparing agendas, presentation materials, and minutes for clinical study team meetings.
- Collate data for feasibility assessments and site selection.
- Review site usability databases.
- Contribute to the review of study documents such as informed consent forms and case report forms.
- Compile and maintain study manuals.
- Manage the electronic Trial Master File (eTMF).
- Track site activation, enrollment, and monitoring visits.
- Escalate any issues or delays in the trial process.
- Monitor investigator/site status.
- Support clinical trial registry postings.
- Contribute to Blind Data Review Meetings.
- 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.
