Clinical Research Associate

Apotex; Bengaluru; On-site; INR 1,000,000 - 2,000,000; Full time

Job summary

Apotex in Bengaluru urgently seeks an experienced Clinical Operations professional to drive study execution in line with SOPs, GCP, and GLP requirements. You will coordinate with study teams, monitor timelines, and ensure data integrity across TMF, CRFs, and regulatory documents.

The role requires 5+ years in Clinical Operations, a pharmacy degree (M.Pharm or B.Pharm), and strong communication skills. You will support safety reporting, site collaboration, and adherence to company policies while

Qualifications

• Minimum of 5 years experience in Clinical Operations.
• Experience in GCP/GLP with strong regulatory compliance.
• Educational background of M.Pharm or B.Pharm.

Responsibilities

• Execute studies per protocol and regulatory guidelines under SOPs and GCP/GLP.
• Coordinate check-ins, protocol training, and study forms with the study coordinator.
• Prepare master templates and check-in/check-out activities for studies.
• Prepare and compile TMF, raw data, study schedules, and study stations.
• Upload study forms and manage data for timely checkout after study completion.
• Review study data for completeness and accuracy in line with protocol and SOPs.
• Distribute meals to subjects as per protocol requirements.
• Perform dosing-related activities and ensure data integrity during the study.
• Coordinate sample transfer and safety follow-up with the team.
• Prepare clinical reports and summary tables for regulatory review.

Skills

Good communication skills

Flexible to work

Education

M. Pharm., /B. Pharm.

Job description

Job Summary

Responsible for execution of the study and system related activities as per the established Standard Operating Procedures (SOP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) best practices and regulatory requirements.

Job Responsibilities

1. Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centers Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
2. Handling and execution of studies as per protocol, SOP and applicable regulatory requirements in a timely manner as per the agreed timelines in coordination with the study coordinator and Investigator.
3. Planning and coordinating for the Protocol Training, Study Check-in activities with the study coordinator.
4. Request, receive the Study Specific pre numbered forms & SOP forms in required number and maintain the timely accountability.
5. Preparation of Master templates, Coordinating for the Check in activities on check-in day and ensuring the completion of Check-in. Ensure sufficient clinical supplies were in place for the study.
6. Preparation and compilation of TMF, Raw data, study schedule, Stations as required for the study.
7. Study Forms uploading and forms generation from Nuleap. Timely checkout of the studies in Nuleap after completion of the study in a timely manner.
8. Performs and ensures clinic staff activities during the study was ongoing in compliance with protocol and SOPs. Review the generated data periodically while the study was ongoing for completeness and accuracy in compliance to protocol and SOPs.
9. Distribution of meals to the study subjects as per the protocol requirements.
10. Performs dosing related activities (such as dosing, dosing supervision, Test Article verification and mouth check).
11. Collection and online review of the collected data during the study such as Subject ICD, Screening Consent Forms and Sample Processing Logs etc.
12. Preparation of study updates & protocol status reports in a timely manner and providing for Investigator and study coordinator for review.
13. Assists and coordinates for the study sample transfer in coordination with study coordinator.
14. Compilation of Subject Case Report Forms,
15. Coordinates for the subject safety and follow up.
16. Preparation and compilation of the Clinical Report along with the summary tables of applicable regulatory and providing for Investigator and study coordinator review.
17. Involves and assists the study coordinator in review of the study data such as Raw data, TMF and CRFs and Clinical Report etc.
18. Clinical Report Section & Case Report Form pdf conversion and book marking for the allocated studies as per the timelines.
19. Initiation, completion of the archival of the study data.
20. Executes other duties as per the study specific protocol requirements and as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
21. Works in a safe manner collaborating as a team member to achieve all outcomes.
22. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
23. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
24. All other relevant duties as assigned.

Job Requirements

Education

• M. Pharm., /B. Pharm.

Knowledge, Skills and Abilities

• Good Communication skills.
• Flexible to work

Experience

Minimum of 5 years experience in Clinical Operations.

Experience in GCP/GLP along with strong compliance in these areas.