Senior Clinical Research Associate (Sr. CRA)

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.