No of openings: 1
Experience : 3 to 5 yrs experience in Clinical Operations.
Job Description :
- Training the teams and new employees regularly and periodically.
- Negotiating the study budgets with the Principal Investigator and executing the Clinical Trial Agreement.
- Assigning and Managing the project team as per the study requirement.
- Development and Revision of departmental SOPs.
- Reviews CRA Site Visit documents (follow up letters and reports).
- Reviews and Approves the travelling plan and budgets of the monitors.
- Updating the sponsor about the progress of the study as agreed in the contract.
- Participating in telecoms with the clients and kick of meetings.
- Hosting the external audits.
- Preparing Monitoring plan for the CRA as per the study specifications and protocol and training the CRA on the same.
- Training the team on study related documents.
- Managing and coordinating all regional CRA activities.
- To perform co-monitoring visits to ensure quality of data generated
- If required accompanying the CRA’s in Qualification visit, Site Initiation Visit and Monitoring visits.
- Organize and present at Investigator Meetings/ Internal meetings.
- Development of project management plan, risk management plans.
- Review the Ethics Committee dossiers as required.
- Review of power point presentations prepared by CRA for investigator meetings, Site Initiation visits.