The St. John's Research Institute (SJRI) is a part of the St John's National Academy of Health Sciences, which is run by the CBCI Society for Medical Education. From its inception, St. John's has set before it an ideal of excellence in academic courses as well as service to society as a result of which it has truly become holistic both in its outlook and in its approach to the problems of community health. In 2000, the Academy decided that its commitment to excellence in research required the setting up of an Institute that was dedicated to the pursuit of research and capacity development in St. John's. This vision encompassed improvement of health of the community and patients through research and development of a Center for Excellence in medical research in India.
Post : Clinical Research Coordinator - Explorer 7/Explorer 8
Brief Description about the Project
1. Interaction with Patients, Sponsor/CRO, IEC, Lab staff and other departments in the institution and conduct the study according to ICH GCP Guidelines, SOPs' and study protocol guidelines and act as the main line of communication between patients, Investigators and CROs in study conduct activities.
2. Assist in Feasibility questionnaires, Coordinate in pre-site selection visit, site initiation visit.
3. Assist the Principle Investigator and Co investigators in screening of subjects by maintaining and updating the list of potentially eligible patients for the ongoing studies
Roles & Responsibilities
• Coordinate in screening, Audio-Video consenting, enrolment, periodic study visits and close out visit.
• Ensure that rights and well being of a research participant is protected throughout the duration of the study.
• Coordinate with finance, legal and regulatory team and assist in the preparation of CTAs specific to the trials.
• Assure all study documentation is maintained by completing the source documents for each
• Patient and maintaining and updating Site Master Files.
• Completing CRFs, e-CRFs on time and resolve data queries.
• EDC, InForm & Medios data capture.
• Ensure and maintain inventory of Study consumables like Investigational product handling, storage, dispensing, accountability, tracking temperature, calibration of equipments, sample centrifugation, courier of documents and lab samples shipment.
• Timely preparation, notification and tracking of the Ethics committee submissions.
• Submission of the study progress, amendments, Protocol Deviations, AE's and SAE's to the ethics committee and sponsor in a timely manner.
• Coordinate with the investigator and the safety monitoring team at the time of SAEs.
• Assist in resolving IEC, DCGI and FDA queries.
• Coordinate and participate in monitoring visits with sponsor/CRO and Facilitating inspections/audits.
• Follow up with patients and document in telephone contact report.
• Conduct study closeout visit and archive the documents.
• Maintain record of closeout studies and resolve the post closeout queries.
Salary : Rs. 20,000/- to be escalated depending on job peformance
Language : English and Kannada
Experience : 0-1 Year
Preferred Qualifications : Degree with life science background, trained in Clinical research (Eg: Diploma in Clinical research,or Msc Clinical research and Pharm.D
Location : Bangalore
To Apply : E-mail cover letter and curriculum vitae with 3 references (names and email addresses / phone numbers) by on or before 11th December, 2023 hemtrials.stjohns@sjri.res.in & cc to hr@sjri.res.in
OR
Last Day for Receiving Application : 11th December 2023
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