Senior Clinical Research Associate (Sr. CRA)

Job Description – Senior Clinical Research Associate

Coordinate all clinical research activities required to ensure data integrity such as data monitoring, protocol compliance, and study documentation, in accordance with Good Clinical Practices.

Responsibilities

  • Support the Clinical Affairs team, field monitors/CRAs and throughout all phases of the clinical projects including study start-up through close-out.
  • Create, organize, and maintain Clinical Files (Master/Project Files, Site Files, and Patient Files) – electronic and physical files.  Maintain TMF file structure, uploads, and tracking of essential documents.
  • Maintain study database and related data management documents.
  • Perform QC check of study documents and data reports.
  • Assist in preparation of study binders, source documents worksheets, study tools, newsletters and other study-related materials.
  • To coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs/worksheets, patient cards, site binders) to study sites.
  • To assist study team with trial progress tracking by updating Project Plans and PowerPoint Slides.
  • To assist in coordination of Investigator, Clinical site, and vendor payments. 
  • Organize internal or external meetings, preparation of agendas and meeting minutes & filing.
  • Assist with coordination of Investigators or Coordinator meetings including meeting materials, travel arrangements, tracking attendance and minutes.
  • Support study inventory/equipment tracking and device management
  • Provide data reports to CRAs in preparation or follow-up of on-site monitoring visits as needed (SIV, IMV, COV).
  • Support company goals and objectives, policies and procedures, Good Clinical Practices, and comply with FDA regulations.

 

Qualifications

  • BS preferred in Life Sciences or other technical discipline.
  • Minimum 5 years related experience, or equivalent, in coordinating clinical trials for medical devices in the United States and outside the United States.
  • Excellent written and verbal communication skills. 
  • Knowledge of FDA regulatory requirements. 
  • Computer literacy is required as are database management skills. 
  • Working knowledge of electronic data collection systems and experience managing contract research organizations.
  • Must have the ability to work with limited supervision. 
  • Must be detail-oriented and have knowledge of  ISO 13485; 2003, 14155, FDA’s Code of Federal Regulations (clinical related regulations) and ICH-GCP regulations.