Job
Description
Greetings from Apotex!!!
Apotex Inc. is Canadas No. 1 Pharmaceutical company and 1 of the top 10 generic companies in USA .Founded in the year 1974,we are the largest Canadian Owned Pharmaceutical Company, operating in various countries worldwide including India and export generics to over 115 countries. Apotex Research Pvt Ltd [ARPL], based at Bangalore is engaged in the development, Bio-Clinical evaluation, manufacturing & distribution of safe & efficacious generic Pharmaceutical Forulations.
Currently we are hiring Registered Pharmacist (Trainee CRA) @ Apotex Bangalore (Bommasandra).
Pharacist License is Required for this role.
Experience: 0 to 2 years
Working Day: Monday to Friday
Job Summary:
Responsible for quality checks of clinical studies as per the established Standard Operating Procedures (SOP), Good Clinical Practices (GCP), applicable Good Laboratory Practices (GLP) best practices and regulatory requirements.
Job Responsibilities:
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.
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.
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, Station as required for the study.
To handle the test article management process for receipt, accountability, packaging and inventory of test articles including controlled substances.
Study Forms uploading and forms generation from Nuleap. Timely checkout of the studies in Nuleap after completion of the study in a timely manner.
Performance and ensure 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 activates (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.
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.
Involves and assists the study coordinator in review of the study data such as Raw data, TMF and CRFs and Clinical Report etc.
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 Operation Management/delegate as training and experience allow.
Coordinates / communicates internal and / or with cross functional departments for study relevant activates.
Involves in the preparation and review of Telugu language ICD prior to finalization.
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.
All other relevant duties as assigned.
Job Requirements:
Education
o Bachelor of Pharmacy. (B. Pharm)
Knowledge, Skills and Abilities
o Good Communication skills.
o MS Office (M-S Word, MS-Power point, MS-Excel)
Experience
o Experience in GCP/ GLP along with strong understanding of compliance in these areas