Clinical Trial Associate
The Clinical Trial Associate provides administrative support to the clinical research teams in the full spectrum of the research activities such as pre-clinical research, study start-up, study management and site closure.
Clinical research associates help to organize and monitor the different phases of clinical trials. Key responsibilities include:
Responsibilities And Duties:
- To assist Project Manager and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
- To assist the clinical team in preparing, handling, distributing, filing, and archiving clinical documentation and reports according to the scope of work and standard operating procedures.
- To assist with periodic review of study files for accuracy and completeness.
- To assist with the tracking and managing Case Report Forms (CRFs), queries and clinical data flow.
- To process Data Collection Forms, i.e. login, tracking, quality control as appropriate for the study.
- To assist in preparing Quality management system documentation and preparation for audits.
- To provide general administrative support to the Clinical Operations Department.
- To assist the Clinical teams in the completion of all required tasks to meet departmental and project goals.
- To set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.), including preparation for internal/external audits, final reconciliation and archival.
- To assist in the coordination of Investigator payments, if applicable.
- To assist in producing slides, overheads, etc., as needed for the project, departmental, sponsor and business development presentations.
Qualifications:
- equivalent experience degree in Clinical Background.
- 2-3 year professional Clinical Background experience
- Excellent oral and written communication skills,
- Professional in-depth knowledge of regulations in the Medical Device industry.
