Research Analyst
QPS Bioserve India · Hyderabad · onsite · Posted today
Undisclosed0–5 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
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.
Sourced from naukri
Skills
bio summary tablesclinical researchclinical trialsbusiness researchRegulatory GuidelinesBiotechnologyclinical study reportclinical protocolsBioequivalence Studies