Project Technical Support II _ ICMR PANCREAS Study Project

Bangalore

The study is an observational study on the nutritional status on children with pancreatitis. The study will involve interaction with children and their parents, IEC, Lab staff and other departments in the institution. The conduct of the study should be according to ICH GCP Guidelines.

Should assist the Principal Investigator and Co investigators in screening of subjects by maintaining and updating the list of potentially eligible patients for the ongoing study and supervise the protocol.

Vacancy: One

Key Responsibilities

• Ensure that rights and well-being of a research participant is protected throughout the duration of the study.
• Assure all study documentation is maintained by completing the source documents for each
• Completing CRFs, e-CRFs on time and resolve data queries.
• Electronic data capture including REDCAP database.
• 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, AEs and SAEs 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 queries.
• Follow up with patients and document in telephone contact report.
• Conduct study closeout visit and archive the documents.

Eligibility Criteria

Preferred Qualifications: Degree with life Science background, nutrition , trained in Clinical research e.g. Diploma in clinical research, or BSC or MSC Clinical research, nutrition or Pharm D

• Minimum Experience: No. required: fresher
• Maximum Experience No. required: 1 year

Experience: 0-6 months, Freshers also acceptable

Preferred Language: English, Kannada, Telugu