QPS Bioserve is hiring for the position of Research Analyst at its Balanagar location in Hyderabad, Telangana. The role involves clinical study synopsis and protocol preparation, clinical study report preparation and review, regulatory documentation, pharmacokinetic and pharmacodynamic study design, and pharmacy activities related to bioavailability and bioequivalence studies.
Candidates with experience in clinical documentation, regulatory guidelines, and clinical study-related activities can review the job responsibilities and apply by sending their CV to the recruitment email address provided below.
Job Details
| Particulars | Details |
|---|---|
| Company | QPS Bioserve |
| Job Title | Research Analyst |
| Location | Balanagar, Hyderabad, Telangana |
| Experience | 0–5 years |
| Number of Openings | 1 |
| Industry | Clinical Research |
| Application Email | hr@qpsbioserve.com |
Position: Research Analyst
The Research Analyst will support clinical research documentation, including the preparation and review of study protocols, study synopses, clinical study reports, informed consent forms, and regulatory submission documents. The role also involves scientific inputs for pharmacokinetic and pharmacodynamic studies and investigational product management for bioavailability and bioequivalence studies.
Responsibilities
1. Study Synopsis Preparation
- Prepare and compile clinical study protocol synopses.
- Prepare and review clinical study protocols according to sponsor requirements and applicable regulatory authorities.
- Prepare informed consent forms.
2. Clinical Protocol and Report Preparation
- Prepare and review Clinical Study Reports (CSRs) according to sponsor requirements and applicable regulatory authorities.
- Prepare and review bio-summary tables, clinical summaries, and CSBE documents for regulatory submissions.
- Design and review scientific and technical inputs for pharmacokinetic and pharmacodynamic studies.
- Review regulatory guidelines and current requirements for clinical research-related activities.
3. Pharmacy Activities
- Dispense investigational drug products according to randomization schedules for bioavailability and bioequivalence studies.
- Issue investigational products (IPs) to the clinical unit before dosing.
- Collect unused investigational products and store them in the pharmacy.
- Review procedures for pharmacy operations.
Eligibility and Required Skills
Candidates should be familiar with the responsibilities associated with clinical research documentation and study operations, including:
- Clinical study synopsis preparation and compilation.
- Clinical study protocol preparation and review.
- Clinical Study Report preparation and review.
- Informed consent form preparation.
- Regulatory guidelines and submission documentation.
- Pharmacokinetic and pharmacodynamic study design.
- Bioavailability and bioequivalence study pharmacy activities.
- Investigational product dispensing, collection, and storage procedures.
How to Apply for QPS Bioserve Research Analyst Recruitment
Interested candidates can send their CV to the following email address:
Email: hr@qpsbioserve.com
