Project Coordinator

Description

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene’ s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time
• Responsible for planning, coordination and overviewing of study-related activities.
• Coordinating with Ethics Committee for review of study-related documents.
• Submission of required documents to Ethics Committee on time for review and approval.
• Submission of study schedule to Ethics Committee.
• Submission of study updates / summary reports to Ethics Committee.
• Reporting major protocol deviations or violations that affect participant safety to Ethics Committee.
• Reporting SAE and submission of detailed reports of the same to Ethics Committee.
• Maintaining all EC-approved general documents (such as advertisements for recruitment of volunteers/participants, compensation plans for research participants, screening CRF, registration consent, general screening consent, Pre-HIV and Post-HIV test forms, etc.) and communication details in appropriate files.
• Arranging protocol training and assisting investigators in delegation of activities to study personnel as per their job responsibilities.
• Coordinating with investigators, screening teams, and study teams during the conduct of the study.
• Coordinating with the PMO team to assist with monitoring visits.
• Coordination with other departments (Central Laboratory, Bioanalytical Laboratory, and Data Management) during the conduct of the study. Accompanying and assisting study-specific monitors during monitoring activities as per the monitoring plan.
• Arrange study ICDs and CRFs and coordinate with the Document Controller for final issuance.
• Responsible for requesting the QA/Document Controller (DC) team to issue the required number of study forms and CRFs well before the start of the study.
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Qualifications

Highest qualification: University

Experience: 8 to 13 years

Education: Master’s in Science (M.Sc.)