About Apotex Inc.
Apotex Inc. is a Canadian-based global health company dedicated to producing high-quality, affordable medicines for patients worldwide. With nearly 7,200 employees in manufacturing, research and development (R&D), and commercial operations, Apotex distributes its medicines to over 75 countries. The company is focused on developing and delivering generic, biosimilar, and specialty pharmaceutical products. For more details, visit www.apotex.com.
Job Title: Clinical Research Associate
Job Summary:
The Clinical Research Associate (CRA) ensures the successful execution of study and system-related activities in compliance with established Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and regulatory requirements.
Key Responsibilities:
Study Operations:
Execute study activities as per study-specific protocol requirements.
Conduct duties in alignment with Apotex Research Pvt. Ltd.’s Bioequivalence Center SOPs and GCP guidelines.
Perform tasks related to requisition, receipt, and accountability of study-specific forms and materials.
Data Management:
Enter study data into required formats or databases for report table and CDISC dataset preparation.
Verify accuracy and completeness of study data and manage storage and retrieval systems.
Assist in the reconciliation of study data and review report tables for accuracy.
Documentation and Coordination:
Maintain proper documentation to ensure readiness for regulatory audits by following GCP and good documentation practices.
Organize clinical files and collect data for database entry in the required formats.
Coordinate and communicate with internal and cross-functional teams regarding study activities.
Compliance and Safety:
Follow all regulatory, compliance, and safety requirements in daily activities.
Ensure adherence to Apotex’s Global Business Ethics and Compliance Program, Global Quality policies, Safety and Environment policies, and HR policies.
Other Duties:
Manage Clinical Study Materials (e.g., receiving, issuing, and storage).
Collaborate as a team member to achieve department goals.
Perform other relevant duties as assigned by Clinical Operations Management or delegates.
Job Requirements:
Education:
B.Pharm, Pharm.D, or B.Sc. in a Life Science-related field.
Experience:
0–2 years of experience in clinical research.
Skills and Abilities:
Proficiency in Microsoft Office (Word, Excel, PowerPoint).
Strong communication skills.
Adaptability and flexibility in work schedules.
Why Join Apotex?
Inclusive Work Environment: Apotex is committed to creating a diverse, supportive, and accessible workplace where all employees feel valued.
Career Growth Opportunities: Work on meaningful projects in clinical research and contribute to global health initiatives.
Accommodations Available: Apotex offers accommodations for applicants with disabilities throughout the recruitment process.
Start your career in clinical research and make a difference in ensuring the safety and effectiveness of medicines for patients worldwide. Apply now!
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Siliguri |Illinois :
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Atlanta | Augusta | Rome |Maine :
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Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
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Frank Scottile Blvd |Missouri :
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New Hampshire |Oklahoma :
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Rostock |Saarland :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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Galway |County Dublin :
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Netherlands |Remote Australia :
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Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Japan | Saitama |Tokyo :
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Turku |Remote Korea :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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