Research Analyst

Role & responsibilities:

Study Synopsis Preparation

• Preparation and Compilation of study Protocol Synopsis.
• Preparation and review of Clinical Study Protocols as per sponsor and/or applicable regulatory authorities.
• Preparation of informed consonant form.

Clinical Protocol Preparation

• Preparation of and review of Clinical Study Reports as per sponsor and/or applicable regulatory authorities.
• Preparation and review of Clinical study report as per sponsor and/or applicable regulatory authorities.
• Preparation and review of Bio Summary Tables/ clinical Summaries/CSBE for different regulatory submissions.
• Responsible for designing and reviewing scientific and technical inputs for pharmacokinetic and pharmacodynamics studies.
• Responsible for reviewing regulatory guidelines with the current requirements for CRS related activities.

Pharmacy Activities

• Responsible for dispensing the investigational drug products as per the randomization schedule Bioavailability / Bioequivalence Studies.
• Issuing IPs to Clinical Unit before dosing and collecting unused IPs and stored in pharmacy.
• Review procedures for pharmacy operations.

Preferred candidate profile: can send the CV to [email protected]