POSITION TITLE:
Clinical Research Associate/
Senior Clinical Research Associate

Duties:

Study Setup and Maintenance

  • Identify and evaluate potential clinical study investigators and service vendors (e.g., central IRBs, laboratories)
  • Assist Clinical Project Managers with day-to-day client, investigator, and service vendor communications
  • Develop supportive study documents such as monitoring templates, study subject tracking tools, study drug shipment and monitoring forms, study manuals, and training materials
  • Develop and maintain clinical study files, ensuring that documentation is accurate, complete, and current at all times
  • Assist Clinical Project Managers with tracking and reporting of project status
  • In accordance with prior experience, this position may include more extensive project management duties such as:
    • Outlining the scope of monitoring needs for new studies, identifying adequate monitoring resources, and managing those resources throughout the course of clinical studies
    • Developing key study documents in conjunction with other functional area leads assigned to a project (e.g., protocols, model informed consent forms, case report forms, data management plans, etc.)
    • Identifying and resolving site performance issues related to protocol/GCP compliance, subject recruitment and/or data capture and retrieval
    • Ensuring the quality of monitoring services provided by regional CRAs

Study Monitoring

  • Work with clients and internal project teams to define study monitoring requirements and develop study monitoring plans
  • Conduct study site monitoring visits (site qualification, study initiation, routine monitoring, study close-out), as necessary
  • Assist Clinical Project Managers with the oversight and tracking of study monitoring activities during the course of a clinical study
  • Work with regional CRAs to ensure timely completion and submission of study site monitoring reports

Other Duties

  • Assist in the development of departmental Standard Operating Procedures, as needed
  • In accordance with prior experience, train entry-level and/or junior CRAs.  Work with the Director, Clinical Operations to develop and implement a CRA training program.

REQUISITE SKILLS, BACKGROUND, AND EDUCATION:

  • Ability to travel as needed (anticipated at 40% - 50% of time)
  • Excellent written and oral communication skills
  • Excellent organizational skills and an astute attention to details
  • Demonstrated ability to function effectively as a study monitor with limited supervision
  • Prior experience observing and training junior CRAs, or performing GCP audits, a definite plus
  • Familiarity with PCs and standard Microsoft Office software applications
  • Minimum of a Bachelor’s degree in a scientific discipline.  Candidates with a BA or clinical training/licensure (e.g., RN, LPN) with appropriate experience will also be considered.
  • Minimum of two years experience as a CRA is required; title will be commensurate with experience.

How To Apply

To apply for a position, please send cover letter and resume to .