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Clinical Research Associate

0-2 years
Not Disclosed
10 Dec. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About Apotex Inc.

Apotex Inc. is a global healthcare company based in Canada, dedicated to producing high-quality, affordable medicines for patients worldwide. With a workforce of approximately 7,200 employees, Apotex is involved in manufacturing, research & development, and commercial operations. The company offers its medicines in over 75 countries globally, focusing on the development and sale of generic, biosimilar, and specialty products. For more information, visit www.apotex.com.


Job Summary

The position is responsible for executing study and system-related activities in compliance with established Standard Operating Procedures (SOP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and regulatory requirements.


Job Responsibilities:

  • Conduct activities in accordance with Apotex Research Pvt. Ltd. Bioequivalence Center's SOPs and relevant regulatory guidelines (GCP, GLP, Safe Work Procedures).
  • Enter study data into required formats/databases for report table preparation and CDISC dataset creation.
  • Perform data collection, recording, retrieval, verification, and manage data storage systems.
  • Review report tables and assist in the reconciliation of study data.
  • Coordinate requisition, receipt, and accountability of study-related forms.
  • Prepare the department for regulatory audits by adhering to good documentation practices, GCP, and relevant SOPs.
  • Organize files and collect clinical data for database entry or required formats.
  • Coordinate and communicate with internal and cross-functional departments for study-related activities.
  • Follow study-specific protocol requirements and assist with other duties as assigned by Clinical Operations Management.
  • Handle clinical study materials (receiving, storage, etc.) in accordance with procedures.
  • Comply with regulatory, safety, and compliance standards.
  • Collaborate as a team member and demonstrate organizational values: Collaboration, Courage, Perseverance, and Passion.
  • Adhere to compliance programs, Global Business Ethics, and Quality policies, Safety, Environment policies, and HR policies.
  • Perform other duties as assigned.

Job Requirements:

Education:

  • B.Pharm / Pharm D / B.Sc. in a Life Science-related field.

Knowledge, Skills, and Abilities:

  • Proficiency in MS Office.
  • Strong communication skills.
  • Flexibility to work in different environments.

Experience:

  • 0-2 years in Clinical Research.

Inclusive Work Environment

At Apotex, we are committed to fostering an inclusive, accessible work environment where all employees feel valued, respected, and supported. Apotex provides accommodation for applicants with disabilities during the recruitment process. If you are contacted for an interview or testing, please inform us if you require accommodations.