Clinical Trial Assistant (CTA)
|Title:||Clinical Trial Assistant (CTA)|
|Department:||Global Clinical Development|
|Job Status:||Full Time|
Celerion is searching for multiple full-time Clinical Trial Assistants (CTAs) that will support the project team by creating and distributing study matierals, tools and documents. The CTA will assist in study management and site management activities to ensure compliance to prtocol, ICH Good Clinical Practices, Standard Operating Procedure and regulatory and local requirements.
- Support the Project Manager and study team in creating, updating and tracking study documents, plans, and summaries.
- Collection, review, logging, tracking of required ICH GCP Essential Documents. Supporting submission of the documents to the Trial Master File department on behalf of the project team. Must have knowledge of the required contents per the local regulations and ICH GCP guidelines to assess completeness.
- Attend project team meetings and complete and distribute agendas and accurate meeting minutes.
- Prepare, send and track materials to study sites as required.
- Sending /tracking/filing Confidentiality Agreement (Confidential Disclosure Agreement and Regulatory Packages to new sites.
- Maintenance of master study status lists and investigator and trial staff contact information (e.g., site activation and enrollment tracking lists or database(s), contact lists, etc.).
- Bachelor's degree preferred in science, nursing, other biomedical discipline, or equivalent preferred.
- Excellent oral and written communication skills.
- Proficient computer skills, i.e., MS Word, Excel, Powerpoint.
- Excellent communication and organization skills.
- Ability to prioritize and multi-task and demonstrate flexibility and attention to detail.*Equivalent education and experience will be considered.