Agency - Clinical Research Physician -Clinical Operation

Job Description

About Apotex Inc.

Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

For more information visit: www.apotex.com .

Job Summary

Responsible for conduct of studies in compliance with the established standard operating procedures (SOPs), Good Clinical Practices (GCP) and applicable regulatory guidelines. Responsible for the overall study subject safety.

• 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.
• Participates as Clinical Investigator/Principal Investigator for assigned BE studies or Clinical trials.
• Responsible for the screening and in-study assessment and medical care of all potential clinical volunteers/subjects.
• Assesses the previous history of the volunteers, performs physical examination, including medical history of the potential volunteers.
• Assesses the previous medical history of the volunteer and performs physical examination of the potential volunteers.
• Reviews screening results and assesses volunteer suitability.
• Judgment of lab reports and reviews applicable clinical reports as required.
• Completion of study participation summary.
• Review the subject eligibility to conform with protocol requirements.
• Confirm the subject comprehension of study activities and ensure that the Informed consent is given prior to entry into study.
• Oversees and assists in the administration of test articles.
• Assesses subjects adverse events and provides appropriate medical follow up in consultation with Principal investigator.
• Handling of the adverse events in concern with subject safety.
• Provides medical counseling to volunteers/ study subjects with abnormal screening results and abnormal post dose out of range results.
• Withdraws subjects as necessary to protect subject safety.
• Reviews subject monitoring and safety data during the conduct of the study.
• Handling of medical emergencies and approves the use of on-site necessary emergency medical equipment for appropriate adverse event follow-up.
• Assists in the creation, development and revision of the Bioequivalence Center's Clinical Operations Department Standard Operating Procedures.
• Supervises the activities of Nurses and Duty Medical Officers for rendering medical services to the subject at the Clinical Facility.
• 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.

• Education
• M.B.B.S/M.D
• Knowledge, Skills and Abilities
• Current experience in patient care
• Familiarity with TPD, FDA ICH and EU Guidance's with respect to the conduct of bioequivalence studies or clinical trials would be an asset
• Experience
• Minimum of 3-4 years experience.

At Apotex, we are committed to fostering 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 to arrange for an interview or testing, please advise us if you require an accommodation.