Clinical Research Coordinator – Sanofi-004 Study

Job Details

Post : Clinical Research Coordinator

Qualification : Degree with life Science background, trained in Clinical research eg

Diploma in clinical research or MSC Clinical research or Pharm D

No. of Vacancy : Two

Language : English, Kannada, Telugu, Tamil

Location : Bangalore, Karnataka

Application due date : 18th November, 2021

Salary : Rs. 15,000/ Month to be escalated depending on job performance

Key Skills

  • 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
  • Assist in Feasibility questionnaires, Coordinate in pre-site selection visit, site initiation visit.
  • 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

Core 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 equipment’s, 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

Specific Activities

  • Ward round participation to evaluate potential patients with indications for screening into clinical trials.
  • Maintain registry for Hemophilia A, Hemophilia B, Afibrinogenemia, Aplastic Anemia.
  • Distribution of Factors for patients in need from World Hemophilia Federation (India).
  • Follow IEC protocols accurately

To Apply : E-mail cover letter, CV, the names & contact details of Referees

To cecil.ross@stjohns.in cc hr@sjri.res.in

For more information please visit our website www.sjri.res.in

Can Contact us on the following Numbers 080-49467010/49467011