Remote Clinical Research Associate (CRA) - Medical Devices

Job Overview

We are looking for an accomplished Clinical Research Associate (CRA) to become a vital member of our team specializing in the medical devices field. This remote position presents an exceptional opportunity for you to monitor clinical trials and ensure regulatory compliance effectively. Your insights will play a pivotal role in advancing innovative medical devices from conception to market, upholding the highest standards of clinical research and patient safety.

Key Responsibilities

• Execute site selection, initiation, monitoring, and closure activities.
• Cultivate and sustain robust relationships with clinical sites and investigators.
• Conduct routine site visits to guarantee adherence to study protocols and regulatory guidelines.
• Scrutinize source documents and confirm the precision of data entry into clinical databases.
• Ensure compliance with Good Clinical Practice (GCP), Institutional Review Board (IRB) regulations, and other applicable standards.
• Prepare for and engage in regulatory inspections and audits.
• Maintain critical documents and study files in accordance with policies and regulatory mandates.
• Assist in the preparation and submission of study-related documentation to regulatory bodies.
• Collaborate closely with cross-functional teams, including clinical operations, data management, and biostatistics, to facilitate timely study progress.
• Provide training and support to site personnel concerning protocols and procedures.
• Develop and deliver monitoring reports, addressing issues and suggesting corrective actions as necessary.
• Track and oversee study timelines and milestones.
  
  

Required Skills

• Profound understanding of clinical trial processes, regulatory requirements, and GCP guidelines.
• Exceptional organizational, communication, and interpersonal abilities.
• Capacity to work independently as well as part of a team in a dynamic environment.
• Competence in Microsoft Office Suite and clinical trial management software.
  
  

Qualifications

• Bachelor’s degree in life sciences, nursing, or a related field; advanced degree preferred.
• At least 2 years of experience as a CRA in the medical device sector.
• Certification (e.g., ACRP, SOCRA) is advantageous.
  
  

Career Growth Opportunities

Our organization is committed to fostering your professional development, offering robust opportunities for continuous learning and expansion of your career within the medical device arena.

Company Culture And Values

We believe in a collaborative and innovative work environment where every team member contributes to improving patient outcomes through state-of-the-art medical devices. Our emphasis on strong relationships with clinical sites promotes teamwork and ensures projects progress in a timely manner.

Employment Type: Full-Time