Clinical Trial Assistant - Lucknow, India - Fusion Market Research

Fusion Market Research

Verified Company

Lucknow, India

2 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

JOB FUNCTIONS/RESPONSIBILITIES:

To provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s).
To assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
To support the Clinical Operations teams with ongoing conduct of studies.

- *To be familiar with ICH GCP, appropriate regulations, relevant ICON SOP's and ICON internal tracking systems.

To be familiar with the roles of the Clinical Research Associates (CRA) including site visits, if appropriate.
To assist project teams with study specific documentation and guidelines as appropriate.

- *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 process Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study.
- *To assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
- *To co-ordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate.
- *To assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
- *To copy and route incoming correspondence, internal documentation, CRFs, etc., as appropriate.

To assist in coordination of Investigator payments, if applicable.

- *To contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).
- *To assist in the tracking and distribution of safety reports.

To coordinate document translation, if required.
To attend project team meetings and generate meeting minutes.
To assist the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations.
To assist with the coordination of team member tracking.
Other duties as assigned