Clinical Trial Assistant

2 days ago

Lucknow, India Fusion Market Research Full time

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 co-ordination 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 co-ordinate 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

**Job Types**: Full-time, Permanent, Fresher

**Salary**: ₹28,000.00 - ₹56,000.00 per month

**Benefits**:

- Health insurance
- Provident Fund
- Work from home

Schedule:

- Day shift
- Morning shift
- Rotational shift

Supplemental pay types:

- Performance bonus
- Yearly bonus

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