Senior Clinical Research Associate

4 days ago

Cambridge, Massachusetts, United States ICON Strategic Solutions Full time
Job Title: Senior Clinical Research Associate

At ICON Strategic Solutions, we are seeking a highly skilled and experienced Senior Clinical Research Associate to join our team.

The successful candidate will be responsible for providing leadership in the execution of clinical studies, ensuring high-quality data is delivered to sponsors on time, within budget, and in compliance with all applicable regulations and procedures.

Key Responsibilities:

  • Develop and maintain compliant clinical study execution practices throughout the organization.
  • Drive the adoption of best practices in clinical research, including research and testing of products involving human subjects.
  • Develop and maintain policies and procedures for the Clinical Operations function.
  • Support the Clinical Trial Management System application for clinical study execution and reporting.
  • Ensure clinical studies are conducted according to procedures, including up-to-date and complete trial master files, regular review of data, and timely completion of monitoring reports.
  • Act as Clinical Study Manager for designated clinical studies, providing guidance and support to team members.
  • Attend required meetings and provide updates to the team.
  • Support EDC user acceptance testing and training as needed.
  • Oversee the creation of trial master files, regulatory binders, source documents, and investigational product ordering and shipping documentation.

Requirements:

  • Qualifications, selection, training, and monitoring of internal and external study investigators and study documentation.
  • Leadership and communication skills to manage site management and collaborate with internal and external business partners.
  • Ability to analyze situations and data to make informed decisions.

About ICON Strategic Solutions:

We are a leading provider of clinical research services, dedicated to delivering high-quality data to our clients. Our team is passionate about advancing medical research and improving patient outcomes.

What We Offer:

  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

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