Senior Clinical Research Specialist

4 days ago

Rajkot, Gujarat, India beBeeResearch Full time ₹ 6,00,000 - ₹ 10,00,000
Job Title

Clinical Research Associate - Study Personnel

About the Role

We are seeking a highly skilled and motivated Clinical Research Associate to join our team. The successful candidate will be responsible for conducting clinical research studies, including toxicology and efficacy studies.

Key Responsibilities
  • Request for required no. of animals
  • Observe the study animals for clinical signs, functional observation battery and mortality
  • Receipt, storage and handling of chemicals, reagents and solutions
  • Dose preparation and dosing of animals via different routes
  • Weighing of animals, feed consumption, body temperature, dermal observations
  • Randomization of study animals
  • Perform pharma-efficacy studies like batch release test i.e., Pyrogen test, Abnormal toxicity test, Potency assays, nodule test etc.
  • Blood collection, separation and storage of samples
  • Preparation of study reports
  • Conduct of study, data collection, compilation and verification
  • Collection of sample(s) / Specimen(s)
  • Preparation and verification of report
  • To participate in Genotoxicity study
  • Data entry from raw data to computer application and further analysis
  • Co-operate during internal, RQA & sponsor audits of study plans, studies, data, reports etc.
  • To participate in standardization of new toxicity study
  • Ensure proper labeling of containers (test item, samples etc.)
Documentation Requirements
  • Document deviation from SOP or study plan and communicate directly with SD.
  • Recording raw data promptly and accurately and in compliance with Principles of GLP.
  • Maintenance of internal records as per in-house SOPs and GLP
  • Update and maintain training records
  • Ensuring the availability of various monitoring certificates such as feed, water, bedding material, health etc.
  • Request for the issuance of controlled / uncontrolled document and maintain the documentation
  • Prepare / revise the SOPs as and when required in accordance with in-house SOP
  • Archive the documents as per in-house SOPs when applicable
  • Document the deviation from study plan or SOP and report the incident to SD or HOS.
  • Record the raw data as and when activities are performed, verify the data and calculation.
  • Results compilation and analysis
Instrument Handling and Maintenance
  • Operate the instruments in accordance with respective instrument SOP, monitor calibration & maintenance of instrumentation in lab
  • Perform the calibration / maintenance of instruments as per in-house SOP

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