Fresher Clinical Research Associate at Apotex
Job Title: Clinical Research Associate
Date Posted: September 10, 2024
Location: Bangalore, KA, IN, 560099
Company: Apotex
About Apotex Inc.
Apotex Inc. is a global health company producing high-quality, affordable medicines in over 75 countries. It employs 7,200 people worldwide in R&D, manufacturing, and commercial operations, specializing in generic, biosimilar, and specialty products.
For more details, visit: www.apotex.com.
Job Summary
The Clinical Research Associate is responsible for the execution of clinical studies and related activities according to Standard Operating Procedures (SOP), Good Clinical Practices (GCP), and regulatory guidelines.
Job Responsibilities
| Core Responsibilities | Details |
|---|---|
| Compliance | Follow Apotex Bioequivalence Center’s SOPs, regulatory guidelines, GCP, and Safe Work Procedures. |
| Data Management | Enter study data in required formats/databases for report table preparation and CDISC datasets. |
| Information Management | Collect, verify, and manage data storage/retrieval systems and review report tables. |
| Study Coordination | Perform study-related tasks as per protocol and coordinate with cross-functional teams. |
| Audit Preparation | Ensure department readiness for regulatory audits by following good documentation practices. |
| Clinical Materials | Handle Clinical Study Materials (receiving, issuing, storage). |
| Compliance & Safety | Work according to regulatory, compliance, and safety requirements. |
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Job Requirements
| Qualification | Details |
|---|---|
| Education | B.Pharm / Pharm D / B.Sc. in Life Sciences. |
| Skills | Proficient in MS Office, strong communication skills, flexible to work. |
| Experience | 0-2 years of experience in clinical research. |
Apotex Inc. is committed to fostering an inclusive, accessible environment. If accommodations are needed during the recruitment process, please advise us.
Meta Description (19 words)
Join Apotex as a Clinical Research Associate. Execute clinical studies per GCP, SOPs, and regulatory guidelines.