The clinical Trial Assistant is responsible for archiving and filing clinical trial documents correctly. Assist in organizing and planning meetings (such as investigator meetings, team meetings, project meetings). In clinical research, assistants prepare and provide documents that must be submitted to the ethics committee and competent authority for approval. CTAs are often employed by CROs and pharmaceutical companies.
Roles and responsibilities of a clinical trial assistant
Here are the lists of some essential tasks performed by a clinical trial assistant;
- The primary functions of this position are to provide general administrative support for the Clinical Operations Department and to assist the Project Manager(s) and Project Director(s).
- Ensure that all tasks required to accomplish the project and departmental goals are completed by the Clinical Operations team.
- To support the Clinical Operations teams with ongoing conduct of studies.
- To have a firm grasp of ICH GCP guidelines, applicable regulations, and processes.
- Helping teams with study-specific guidelines and documentation, as needed.
- Maintain the documentation of all clinical studies (e.g. Main Study File, CRFs, etc.) including preparation for internal/external audits, final reconciliation, and archiving.
- Processing Data Collection Forms, including login, tracking, and quality control according to study needs.
- Provide assistance in quality control audits of clinical study documentation (e.g. main study files, CRF files, monitoring files, etc.).
- Coordinate the ordering, dispatch, and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, and drug supplies).
- Update the Clinical Trial Management systems so that project teams can track progress with their trials.
- Participate in project team meetings and prepare minutes of meetings.
- The aim of this role is to assist the Project Manager and the project team with the coordination of Investigator Meetings, activities preparation, and the production of minutes of the meeting.
- For presentations for projects, departments, sponsors, and/or business development, you will develop slides, overheads, etc.
Educational Qualification required to become a CTA
So, what qualification you would require to become a clinical trial assistant? You require a basic life science qualification and a diploma, advanced diploma, or post-graduation in clinical research.
How much does a clinical trial assistant earn?
Employees who work at CTA earn an average of *18lakhs, most of whom make between *12lakhs per year and ₹24lakhs per year. 10% of the employees earn more than ₹24lakhs per year. Clinical Trial assistants are employed by CROs or Pharmaceutical companies and play an essential part in the clinical trial.