Regional CRA

Princeton, NJ
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Type: Contract

Category: Scientific & Clinical

Job ID: 167104

Date Posted: 11/30/2020


 

Regional CRA- United States

Contract Length: 6 mos

Number of Openings: 2

Job Description:

  • Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions.
  • Ensures validity of study by identifying/resolving discrepancies and obtaining missing data and may track core lab activities and more complex components of the trial.
  • Contributes to developing and writing clinical protocols, case report forms, and other study aids for investigational products by addressing issues by interacting with appropriate personnel.
  • Maintains expertise in regulations for applicable geographies and types of studies (IDE, non­ significant risk, feasibility, exempt, etc.). Serves as a resource related to clinical trial regulations.
  • May mentor and train new employees.
  • Serves as a trainer for contract research organizations (CROs) needed for additional monitoring support
  • Ensures timely collection of study documentation by obtaining, maintaining and controlling all necessary records and documentation according to procedures and regulations.
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • Other miscellaneous duties as may be required.

Accountability/Scope/Budget

  • Excellent Communications skills, both oral and written.
  • Ability to initiate, plan and manage projects.
  • Strong decision-making skills and ability to prioritize.
  • Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.

Knowledge:

  • International Harmonized /Committee Good Clinical Practices, IHC/GCP.
  • Current Good Manufacturing Practice 21 CFR Part 820 is an asset.
  • Knowledge of project management tools and techniques.
  • Broad knowledge and application of business concepts, procedures and practices.
  • Advanced English Oral/Written.

 

Requirements:
  • Bachelor's degree or equivalent experience required; prefer background in the sciences or a medically-related area (such as but not limited to Biology, Chemistry, Nursing, Medical Technology, Respiratory Therapy or related field of study).
  • Require 3-6 years on-site monitoring experience
  • Travel up to 30% of the time domestically and / or internationally may be required.

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