23 days old

Clinical Research Assoc III

Parsippany, NJ 07054
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!

We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day.  We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com

 

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.

Responsibilities:

  • 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

Bachelors 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
In process of validation
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.

Categories

Posted: 2020-01-24 Expires: 2020-02-27

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Clinical Research Assoc III

Teva Pharmaceuticals
Parsippany, NJ 07054

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