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Clinical Research Associate

Date: May 17, 2021

Location: Toronto, Ontario, CA, M1B2K9

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

The Clinical Study Coordinator (CSC) will be responsible for assisting the CSM in conducting activities pertaining to PD/CE studies for the projects assigned to the CSM.  The CSC might be involved in non-study related activities depending of the needs in the department.
 

The following is an outline of the responsibilities and duties of the CSC, but is not all inclusive:
 

  • Management of Investigational Products and Ancillary Supplies.
  • Responsible for operational study oversight activities as delegated by the CSM.
  • Posting and maintenance of trials on CT.gov.
  • Coordination with development sites on the regulatory package creation for trial approval per local requirements and where needed to support global functions.
  • Maintenance and review of the Trial Master File (TMF).
  • Review of study specific documents and Case Report Forms.
  • Review of monitoring reports and informing the CSM of any critical findings.
  • Review and preparation of the final study reports as delegated by the CSM.
  • Participate in User Acceptance Training (UAT) for study specific electronic systems.
  • Investigator meeting planning and tracking.
  • To assist in the response to deficiency letters or audit observations by regulatory authorities.
  • Maintenance of BPG records and updating as needed with the direction of the CSM.  

Qualifications

  • Bachelor’s Degree in the field of Pharmacy, Chemistry, Biology, or any related Science field.
  • 3+ years experience in pharmaceutical or clinical research related field
  • Knowledge of Good Clinical Practice (GCP) and International Council for Harmonization (ICH) guidelines and other requirement relative to clinical study conduct.
  • Shipping of Investigational product both in North America and Internationally
  • Familiarity with Trial Master File contents and structure
  • Familiarity with Clinical Protocols and study plans.
  • General knowledge of computers, Microsoft Office, and can quickly pick up on new software systems. Experience in electronic systems such as Electronic Data Capture and Randomization Systems is also an asset.

Function

Research & Development

Sub Function

Clinical Development

Reports To

Associate Director, Clinical R&D

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.