Site Solution Executive

Location: Mysore.

This is a contract position with a duration of 1 year.

What Youll Be Doing:

• Coordinates and facilitates all Clinical trial activities at site ensuring compliance with protocol, applicable GCP guidelines and local regulations;
• 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,
• Reviews the site processes, identifies gaps and supports roll-out of site processes.
• The following key functions are required routinely:
• Performs timely data entry of the Case Record Forms (CRF) or Electronic CRF (eCRF) in consultation with the PI/Investigator
• Maintaining clinical trial-related documents at site including Trial Master File.
• 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.
• Reporting site-performance metrics at pre-determined frequency.
• 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.
• Assisting in scheduling patient investigations and assessments per instructions of Principal Investigator
• 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
• Assuring that all work at site prescribed by the approved protocol, the contract and the EC is performed in a timely and comprehensive manner
• Organizing and coordinating laboratory sample pick-ups and reporting
• 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.
• Assisting in timely resolution of data queries
• Coordinating and supporting timely completion of protocol-related procedures by the PI, specifically subject scheduling, subject screening and enrolment
• Maintaining regular contact with site monitor regarding patient enrolment, visit scheduling, dosing/dispensing
• Facilitating cordial and timely communication between investigator and sponsor/CRO - Supporting patient-awareness, training or other events at site or in the neighborhood
• Supporting data collection activity at site including but not limited to feasibilities, epidemiological data
• To create the database of potential patients that can be enrolled into the study as per the protocol
• To identify any challenges and find out mitigation plan in advance with the support of LM, TSM & PI
• Responsible to complete all mandated training and ongoing training modules and SOPs
• Responsible for notifying Sponsor / CRO representatives of external audits/ inspections by the sponsor and regulatory authorities respectively.
• Collaborates with PI to respond to any audit findings and implement approved recommendations.
• Escalate systemic non-compliance and/or misconduct to his /her manager for appropriate follow-up.
• Directs all feasibilities coming to the site to feasibility team at CS.

What we are looking for:

• A Bachelors or Master's degree in clinical, biological or mathematical sciences or related fields, or a medical or dental degree or a nursing qualification; Exceptions to this would require a minimum of 4 years of experience of working at clinical research sites.
• Good oral and written communication skills in English and at least one local Indian language
• Excellent interpersonal skills
• Good coordination and organizational skills and also problem-solving and analytical skills
• Attention to detail and documentation and conscious of the importance of time and data accuracy in the clinical trial context
• Conscious of ethical and scientific requirements and of patient-safety and patient-rights in the clinical trial context
• Familiarity with computer usage and office communication tools