Senior Clinical Trial Assistant

The Senior Clinical Trial Assistant (Sr. CTA) is required to help support Clinical Operations and project teams. The position offers much responsibility and the opportunity to be involved in all phases of the clinical project. The position requires adaptability and the capacity to ‘own’ tasks, problem solve and to see activities through to their end.

Directly support under the guidance of Operational Leaders, Clinical Leaders, and Clinical Trial Managers. Specific responsibilities include:

Responsibilities:

• May participate in reviewing, formatting and finalizing study-related templates, plans and manuals
• Assist in the planning, organizing and execution of study-specific meetings and write and distribute agendas, minutes and regular updates
• Responsible for the completeness of documents managed in the Trial Master Files (TMF); performs ongoing reviews of TMF to assure quality of the documentation files and compliance with SOPs and ICH GCP Guidelines
• Maintain and manage requests for access to and deactivation of study systems users.
• Develop and maintain study-related trackers that will support Clinical Operations and individual studies. May analyze or update data associated with the trackers
• May participate in clinical data review, as required
• Assist with maintaining clinical trial insurance
• Maintain and manage requests for access to and deactivation of study systems users.
• May participate in clinical data review, as required
• Coordinates materials (PowerPoint presentations, templates, outstanding essential document listing, etc.) as needed for internal and external meetings, including requests for materials from external consultants, suppliers, etc.
• Assist in the planning, organizing and execution of study-specific meetings and write and distribute agendas, minutes and regular updates
• Assist with questions, issues or requests from the Clinical Research Organization (CRO)/study team and route to the appropriate individual within the organization for resolution
• Distribute safety alerts and relevant documents, if required
• Other duties as assigned to support Study Team Leads and Operational Team Leads
• Assist with maintaining clinical trial insurance
• Distribute safety alerts and relevant documents, if required
• Coordinates materials (PowerPoint presentations, templates, outstanding essential document listing, etc.) as needed for internal and external meetings, including requests for materials from external consultants, suppliers, etc.
• Maintain and update study team and vendor contact information
• Assist with questions, issues or requests from the Clinical Research Organization (CRO)/study team and route to the appropriate individual within the organization for resolution
• Interact directly with Clinical (e.g., CRAs, trial managers), site staff, vendors (U.S. and worldwide, as necessary), to provide support in project-specific tasks and the overall management of clinical trials
• Maintain and update study team and vendor contact information
• May participate in reviewing, formatting and finalizing study-related templates, plans and manuals
• Route, track and file Clinical documents. May conduct initial/ongoing review of site Clinical regulatory documentation to confirm completeness/track dates and distribute to appropriate team members for review

Qualifications:

• Bachelor’s degree in a relevant subject area is highly recommended or a combination of education and applicable job experience may be considered. (2+ years in the biotech /pharmaceutical industry /clinical trial management area)
• Proactive and self-starter with the ability to take responsibility for tasks and execute seamlessly. Be able to identify areas for efficiency across studies in the spaces that the position is responsible for.
• Strong interpersonal, organizational and planning skills along with excellent verbal and written communication skills
• Competency of the drug development process with knowledge of ICH-GCP is a plus
• Ability to travel up to 35%