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Clinical Operations Senior Clinical Research Associate

1 month ago

Cambridge, Massachusetts, United States ICON Strategic Solutions Full time
Job Title: Sr. CRA

**Job Summary:**

We are seeking a highly skilled and experienced Senior Clinical Research Associate (CRA) to join our Clinical Operations team at ICON Strategic Solutions. 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:**

  • Provide 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.
  • Drive the adoption of compliant clinical study execution practices throughout the organization, including research and testing of products involving human beings.
  • Develop and maintain policies and procedures for the Clinical Operations function of Clinical and Medical Affairs.
  • Support, update, and maintain 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 assurance that monitoring reports are completed within two weeks of visit date.
  • Ensure monitoring plans are created and followed, with monitoring documentation included in the applicable Trial Master Files.
  • Act as Clinical Study Manager for designated clinical studies under the guidance of your Manager and may support other studies in this role as applicable.
  • Attend all required meetings and provide updates to the team.
  • Support EDC user acceptance testing and training as applicable.
  • Oversee and support the creation of the trial master file, regulatory binder, source documents, and investigational product ordering, shipping, and associated documentation.
  • The Clinical Operations Senior Clinical Research Associate is responsible for monitoring and leading the monitoring of clinical research studies involving human subjects from inception to close-out according to budget and timelines.
  • Qualify, select, train, and monitor internal and external study investigators and study documentation.
  • May be the lead for site management and expected to communicate well with internal and external business partners, including key opinion leaders.
  • Work on issues where analysis of situation or data requires review of relevant factors.
  • Typically acts as a lead, coordinating the work of Specialist or Coordinator, but is not a supervisor.

**Requirements:**

  • Strong leadership and communication skills.
  • Experience in clinical research operations, including clinical trial management and monitoring.
  • Knowledge of clinical trial regulations and guidelines.
  • Ability to work independently and as part of a team.
  • Strong analytical and problem-solving skills.
  • Ability to prioritize tasks and manage multiple projects simultaneously.

**What We Offer:**

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