Clinical Research Associate

Job Role :

Location:

Job Responsibilities :

1. Request for required no. of animals

2. Observe the study animals for clinical signs, functional observation battery and

mortality

3. Receipt, storage and handling of chemicals, reagents and solutions

4. Dose preparation and dosing of animals via different routs

5. Weighing of animals, feed consumption, body temperature, dermal observations

6. Randomization of study animals

7. Perform pharma-efficacy studies like batch release test i.e., Pyrogen test, Abnormal

toxicity test, Potency assays, nodule test etc.

8. Blood collection, separation and storage of samples

9. Preparation of study reports

10. Conduct of study, data collection, compilation and verification.

11. Collection of sample(s) / Specimen(s).

12. Preparation and verification of report.

13. To participate in Genotoxicity study

14. Data entry from raw data to computer application and further analysis

15. Co-operate during internal, RQA & sponsor audits of study plans, studies, data,

reports etc.

16. To participate in standardization of new toxicity study

17. Ensure proper labeling of containers (test item, samples etc.)

Documentation:

1. To document deviation from SOP or study plan and communicate directly with SD.

2. Recording raw data promptly and accurately and in compliance with Principles of

GLP.

3. Maintenance of internal records as per in-house SOPs and GLP

4. Update and maintain training records

5. Ensuring the availability of various monitoring certificates such as feed, water,

bedding material, health etc.

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

documentation

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

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

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

HOS.

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

calculation.

11. 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