Clinical Research Coordinator

6 days ago


chandigarh, India GastroLab India Pvt. Ltd Full time
About GastroLab India Private Limited
GastroLab 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 description
The 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 physicians
3. Review and comprehend each assigned protocol, including study proceedings and timelines
4. Work closely with the PI & participants in an integral way in the informed consent process by communicating clearly with potential study subjects about the protocol
5. Coordinate approval of new study agreements and contracts
6. Coordinate and attend sponsor site selection visits, routine monitoring visits, and study close-out visits
7. Complete case report forms and extract data from patient files (source documents) promptly
8. Respond to data clarification requests on time
9. Attend investigator meetings requiring travel and report pertinent information back to research team members
10. Coordinate with the departments to help ensure that clinical research and related activities are performed in accordance with protocol, SOP, GCP, and applicable regulatory requirements
11. 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 training
12. Maintain subject screening logs and protocol deviation logs
13. Maintain an Excel sheet for tracking updates to the database of all subjects enrolled in clinical trials
14. Coordinate and facilitate monitoring and auditing visits and notify appropriate institutional officials of external audits
15. Collaborate with PI and institutions to respond to any audit findings and implement approved recommendations
16. 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

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