Senior Clinical Research Associate

Lifelancer
South Bend, IN
Category Healthcare
Job Description
Role Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.

What You Will Do

Perform site monitoring visits, administer protocol and related study training, evaluate the quality and integrity of study site practices, manage the progress of assigned studies, and ensure copies/originals site documents are available for filing.

Why It Might Be a Fit

Requires at least 2 years of on-site monitoring experience, good knowledge of clinical research regulatory requirements, and good therapeutic and protocol knowledge.

Requirements

  • Bachelor's Degree in scientific discipline or health care
  • At least 2 years of on-site monitoring experience
  • Good knowledge of clinical research regulatory requirements
  • Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

Benefits

  • Health and welfare benefits
  • Incentive plans, bonuses, and/or other forms of compensation
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