Clinical Research Associate

0-2 years

Not Disclosed

Bangalore

10 Dec. 2, 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 Canadian-based global health company that produces high-quality, affordable medicines for patients worldwide. With nearly 7,200 employees globally, Apotex operates in manufacturing, R&D, and commercial sectors, providing medicines to patients in over 75 countries. The company is focused on developing and selling generic, biosimilar, and specialty products through vertical integration.
For more information, visit: www.apotex.com.

Job Summary
Responsible for executing study and system-related activities according to established Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and regulatory requirements.

Job Responsibilities

Conduct duties following Apotex Research Pvt. Ltd., Bioequivalence Center’s SOPs, regulatory guidelines, and GCP requirements.
Enter study data into required formats/databases for report table preparation and CDISC datasets.
Collect, record, and verify information; manage data storage and retrieval systems.
Review report tables and perform activities related to requisition, receiving, and accountability of forms for the study.
Ensure departmental readiness for regulatory audits by adhering to documentation practices and SOPs.
Organize files and collect clinical data for database entry.
Assist in study data reconciliation and coordinate with internal and cross-functional departments.
Perform study activities per protocol and additional duties as assigned.
Handle Clinical Study Materials (receiving, issuing, storage, etc.).
Adhere to all regulatory, compliance, and safety requirements.
Collaborate as a team to achieve outcomes and demonstrate organizational values: Collaboration, Courage, Perseverance, and Passion.
Adhere to compliance programs, global quality policies, safety and environment policies, and HR policies.
Perform other relevant duties as assigned.

Job Requirements

Education:

B.Pharm / Pharm D / B.Sc. in Life Sciences or related field.

Knowledge, Skills, and Abilities:

Proficient in MS Office.
Strong communication skills.
Flexible to work in different environments.

Experience:

0-2 years in Clinical Research.

At Apotex, we are committed to creating an inclusive, accessible work environment where all employees feel valued, respected, and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted for an interview or testing, please let us know if you require any accommodation.

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Clinical Research Associate

Job Description

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