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Job Description
- The CRA will be expected to do Internet research and prepare a summary for the PK properties and methods of analysis (in vitro & in vivo) of requested APIs.
- The CRA is expected to make sample size calculations for the clinical studies of awarded contracts.
- Using up-to-date pharmacopeia data, the CRA will assist the technical staff in reviewing and preparing methods of analysis for the in vitro work.
- CRA will be responsible for preparing BE study protocols and submitting the protocol to center managers and drug companies for approvals.
- CRA will work with the Quality Assurance Officer and other staff to prepare all study documents before execution of the clinical trial.
- CRA will work with the technical staff to clean-up and finalize both invitro and invivo raw data in preparation for report writing.
- CRA will assist the senior staff in PK parameters calculations.
- CRA will assist senior staff in the BE report preparation.
- CRA will assist the senior scientists in a timely manner in addressing comments received from the BE Committee on submitted studies.
- As deemed necessary, the CRA may assist senior staff in liaising with drug companies.
Job Requirements
- Bachelor in Pharmacy.
- Analytical chemistry background.
- Reporting experience.
- Pharmaceutical experience.
