Senior Clinical Research Associate

Apotex Inc.; Bengaluru; On-site; INR 1,200,000 - 1,500,000; Full time

Job summary

Apotex Inc. is seeking an experienced Clinical Operations professional to drive execution of studies in accordance with SOPs, GCP/GLP, and regulatory standards at our Bengaluru center.

You will coordinate protocol training, manage study documentation, and liaise with study teams to maintain timelines and quality across all activities. A strong background in clinical operations and compliance is essential to succeed.

Qualifications

• Minimum of 5 years experience in Clinical Operations.
• Experience in GCP/GLP along with strong compliance in these areas.
• Education: M. Pharm. or B. Pharm.

Responsibilities

• Perform study duties per SOP, GCP/GLP and regulatory requirements.
• Coordinate protocol trainings and study check-ins with the study coordinator and Investigator.
• Prepare master templates and ensure check-in completion and adequate clinical supplies.
• Manage TMF, Raw data, study schedules, and CRFs; ensure timely study completion in Nuleap.
• Review data for completeness and accuracy while study is ongoing; ensure compliance with protocol and SOPs.
• Assist with study sample transfer and preparation of clinical reports and status updates.

Skills

GCP/GLP compliance

Regulatory compliance

Clinical operations

Study coordination

Education

M. Pharm.

B. Pharm.

Job description

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com.

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:

• Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Center's Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
• 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.
• Planning and coordinating for the Protocol Training, Study Check-in activities with the study coordinator.
• Request, receive the Study Specific pre numbered forms & SOP forms in required number and maintain the timely accountability.
• 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.
• Preparation and compilation of TMF, Raw data, study schedule, Stations as required for the study.
• Study Forms uploading and forms generation from Nuleap. Timely checkout of the studies in Nuleap after completion of the study in a timely manner.
• 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.
• Distribution of meals to the study subjects as per the protocol requirements.
• Performs dosing related activities (such as dosing, dosing supervision, Test Article verification and mouth check).
• Collection and online review of the collected data during the study such as Subject ICD, Screening Consent Forms and Sample Processing Logs etc.
• Preparation of study updates & protocol status reports in a timely manner and providing for Investigator and study coordinator for review.
• Assists and coordinates for the study sample transfer in coordination with study coordinator.
• Compilation of Subject Case Report Forms,
• Coordinates for the subject safety and follow up.
• Preparation and compilation of the Clinical Report along with the summary tables of applicable regulatory and providing for Investigator and study coordinator review.
• Involves and assists the study coordinator in review of the study data such as Raw data, TMF and CRFs and Clinical Report etc.
• Clinical Report Section & Case Report Form pdf conversion and book marking for the allocated studies as per the timelines.
• Initiation, completion of the archival of the study data.
• 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.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• 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.

Job Requirements:

• Education: M. Pharm., /B. Pharm.

Experience :

• Minimum of 5 years experience in Clinical Operations.
• Experience in GCP/GLP along with strong compliance in these areas.