Job Role : Clinical Research Associate - Study Personnel (Toxicology & Efficacy) Location: Dholka, Gujarat 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
Job Title
Clinical Research Associate