Remote Clinical Research Associate (CRA) - Medical Devices

Job OverviewWe are actively seeking a detail-oriented Clinical Research Associate (CRA) to become an integral part of our dynamic team within the medical devices sector. This remote position offers the unique opportunity to monitor clinical trials and ensure adherence to critical regulatory standards, thereby facilitating the development of pioneering medical devices from concept to market.

Key Responsibilities

• Conduct site selection, initiation, monitoring, and closure activities.
• Foster and maintain strong relationships with clinical sites and investigators.
• Perform regular site visits to verify compliance with study protocols and regulatory guidelines.
• Review source documents to ensure accurate data entry into clinical databases.
• Ensure that all activities comply with Good Clinical Practice (GCP), Institutional Review Board (IRB) regulations, and other pertinent standards.
• Prepare for and engage in regulatory inspections and audits.
• Maintain essential documents and study files following established policies and regulatory requirements.
• Assist in the preparation and submission of study-related documents to regulatory agencies.
• Collaborate closely with cross-functional teams, including clinical operations, data management, and biostatistics, to promote timely progress of studies.
• Provide training and support to site personnel in relation to protocols and procedures.
• Prepare and present monitoring reports, addressing issues and recommending corrective actions as necessary.
• Track and manage study timelines and milestones.

Required Skills

• Profound understanding of clinical trial processes, regulatory requirements, and GCP guidelines.
• Exceptional organizational, communication, and interpersonal skills.
• Proficiency in Microsoft Office Suite and clinical trial management software.
• Ability to function both independently and collaboratively in a fast-paced environment.

Qualifications

• Bachelor’s degree in life sciences, nursing, or a related field; advanced degree is preferred.
• Minimum of 2 years of experience as a CRA in the medical device industry.
• Strong attention to detail with effective problem-solving skills.

Career Growth OpportunitiesThis position offers significant potential for career advancement within the clinical research domain, particularly in the medical devices industry. You will gain exposure to diverse processes and technologies that will enhance your professional trajectory and open new avenues for development.

Company Culture And ValuesWe foster a collaborative work environment that values communication and teamwork among cross-functional teams. Our culture encourages initiative while ensuring compliance and quality across all clinical research efforts.

Networking And Professional OpportunitiesJoining our organization will provide you with valuable networking opportunities and the chance to develop your skills while working alongside talented professionals dedicated to innovation and excellence in the medical devices sector.

Employment Type: Full-Time