You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
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Coordinates and facilitates all Clinical trial activities at site ensuring compliance with protocol, applicable GCP guidelines and local regulations;
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Supports Principal Investigator (PI) and site study team assuring that the clinical trial(s) being conducted meet all the criteria set by the sponsors and regulators,
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Reviews the site processes, identifies gaps and supports roll-out of site processes.
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The following key functions are required routinely:
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Performs timely data entry of the Case Record Forms (CRF) or Electronic CRF (eCRF) in consultation with the PI/Investigator
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Maintaining clinical trial-related documents at site including Trial Master File.
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Preparing for, facilitating and assisting at site initiation, monitoring and close-out visits protocol-prescribed and other necessary patient-visits, QA visits, sponsor visits and Inspections.
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Reporting site-performance metrics at pre-determined frequency.
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Coordinating submissions to ethics committee of protocol, adverse events and periodic study reports for review and ensuring that all documentation to and from ethics committee is appropriately maintained.
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Assisting in scheduling patient investigations and assessments per instructions of Principal Investigator
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Ensuring timely availability of IP and Lab kits and other clinical trial supplies and ensuring IP is appropriately stored, maintaining temperature logs where necessary; also maintaining IP accountability and accurate record of all clinical trial supplies including lab kits; dispensing of IP to subjects per the protocol under the supervision of the PI
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Assuring that all work at site prescribed by the approved protocol, the contract and the EC is performed in a timely and comprehensive manner
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Organizing and coordinating laboratory sample pick-ups and reporting
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Transcribing source documents if required under the supervision of the PI or designated person and ensuring that they are reviewed and signed off by the responsible person.
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Assisting in timely resolution of data queries
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Coordinating and supporting timely completion of protocol-related procedures by the PI, specifically subject scheduling, subject screening and enrolment
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Maintaining regular contact with site monitor regarding patient enrolment, visit scheduling, dosing/dispensing
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Facilitating cordial and timely communication between investigator and sponsor/CRO - Supporting patient-awareness, training or other events at site or in the neighborhood
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Supporting data collection activity at site including but not limited to feasibilities, epidemiological data
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To create the database of potential patients that can be enrolled into the study as per the protocol
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To identify any challenges and find out mitigation plan in advance with the support of LM, TSM & PI
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Responsible to complete all mandated training and ongoing training modules and SOPs
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Responsible for notifying Sponsor / CRO representatives of external audits/ inspections by the sponsor and regulatory authorities respectively.
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Collaborates with PI to respond to any audit findings and implement approved recommendations.
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Escalate systemic non-compliance and/or misconduct to his /her manager for appropriate follow-up.
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Directs all feasibilities coming to the site to feasibility team at CS.
