Company: Sun Pharma Ltd
Post: Senior Research Scientist – BA/Be studies / Clinical Trial
Experience: 4 to 8 year
Location: Mumbai
Roles and Responsibilities
- Monitoring of outsourced clinical studies on healthy subjects and patients to ensure that studies are conducted and data are recorded and reported in accordance with the protocol, Good Clinical Practices (GCP), Good Laboratory Practices (GLP), predetermined set of Standard Operating Procedures (SOPs) and applicable ethical and regulatory requirements.
- To prepare study monitoring plans and agenda, scheduling the monitoring visits, detailing the monitoring reports and close out of the monitoring reports/activities.
- To perform Site Selection Visit (SSV), Site Initiation Visit (SIV), Site Monitoring Visit (SMV) and Site Closeout Visit (SCV).
- To interact closely with the Contract Research Organizations and study sites for study monitoring activities.
- Prepare and submit written monitoring visit report and monitoring visit follow-up report for study monitoring activities detailing the observations and proposed action to the Sponsor and Investigator/CRO, respectively.
- Review the study protocols for technical inputs.
- Coordinate with relevant stakeholders for study-specific clinical/bioanalytical inputs to facilitate the study monitoring as and when required.
- To review clinical study reports along with the bioanalytical method validation and analytical reports.
- Verify the trial master files for content and completeness at the clinical/investigator sites and manage/maintain the trial master files for the sponsor.
- Prepare and review of SOPs and support training activities as and when required.
- Provide support for audit and quality assurance activities for the outsourced studies.
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