Research Associate

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CRO - Pre Clinical

Role & responsibilities

Test item controller (Pre-Clinical Facility):

1. Receipt of the test materials i.e., test / reference item / vehicle placebo etc. received from sponsor or in-house for Pre-clinical studies

2. Verify the test materials and related documents at receipt, label it and store at appropriate storage condition in accordance with the in-house SOPs

3. Communicate with management or designee for any discrepancies of test materials and documentation

4. Maintain the inventory of test materials received

5. Archive the representative quantity of test materials and document the issuance as per in-house SOPs

6. Provide TIDS and CoA of test materials to study team

7. Receive the request from study team, issue the requested quantity and document the issuance

8. Discard the returned test formulation in accordance with in-house SOPs, where applicable

Microbiology laboratory study personnel:

1. Perform microbial analysis of feed and water

2. Perform microbial analysis of animal health monitoring samples for bacteriology and virology and submit the reports to the concerned animal house in-charge

3. Preparation of various medias required for microbial analysis

4. Perform various microbial efficacy assays i.e., MIC of drugs tested in-vitro

5. Perform bacterial reverse mutation (AIMS) test

6. Culture growth in the media and its viable count.

7. Plate reading at given wavelength with ELISA plate reader.

8. Culture revival and its cell bank preparation for culture preservation.

9. Drugs serial dilutions & combination preparation.

10. Assist in preparation of study plan and report.

Documentation:

1. Request for the issuance of controlled / uncontrolled document and maintain the documentation

2. Prepare / revise the SOPs as and when required in accordance with in-house SOP

3. Archive the documents as per in-house SOPs when applicable

4. Document the deviation from study plan or SOP and report the incident to SD or HOS.

5. Record the raw data as and when activities are performed, verify the data and calculation.

6. Results compilation and analysis

Instrument handling and maintenance:

1. Operate the instruments in accordance with respective instrument SOP, monitor calibration & maintenance of instrumentation in lab

2. Perform the calibration / maintenance of instruments as per in-house SOP