Clinical Research Coordinator

About GastroLab India Private LimitedGastroLab is a state-of-the-art start-up company set to revolutionise how gastroenterologists and individuals approach and manage GI health. Our purpose is to bridge the gap in gastroenterology diagnostics and serve the unmet needs, enabling evidence-based management of symptoms and conditions.Utilising advances made in technology by the brightest minds around the world. We are making early and non-invasive health screening accessible, affordable, and actionable for Indians everywhere. We are a start-up, self-funded organisation working closely with innovative healthcare companies.About the job descriptionThe selected candidate's day-to-day responsibilities include:1. Conduct GI Physiology, electrogastrography, laboratory and manometry/pH testing independently for adult and pediatric patients and ensure SOP adherence. Work on facilitating and coordinating the daily clinical study activities while playing a critical role in the conduct of the study.2. Schedule study subject appointments and serve as the patient liaison to the PI and other participating physicians3. Review and comprehend each assigned protocol, including study proceedings and timelines4. Work closely with the PI & participants in an integral way in the informed consent process by communicating clearly with potential study subjects about the protocol5. Coordinate approval of new study agreements and contracts6. Coordinate and attend sponsor site selection visits, routine monitoring visits, and study close-out visits7. Complete case report forms and extract data from patient files (source documents) promptly8. Respond to data clarification requests on time9. Attend investigator meetings requiring travel and report pertinent information back to research team members10. Coordinate with the departments to help ensure that clinical research and related activities are performed in accordance with protocol, SOP, GCP, and applicable regulatory requirements11. Assists the PI in the development of materials and tools necessary to appropriately train individuals involved in the conduct of the study, like study protocol requirements, schedule of visits, execution of research plan and maintaining records and other documentation of training12. Maintain subject screening logs and protocol deviation logs13. Maintain an Excel sheet for tracking updates to the database of all subjects enrolled in clinical trials14. Coordinate and facilitate monitoring and auditing visits and notify appropriate institutional officials of external audits15. Collaborate with PI and institutions to respond to any audit findings and implement approved recommendations16. Complete documentation on each study visit that is used to track all study-related activities so that time, effort, and materials can be accounted for monthly PRB