Clinical Research Associate (CRA) - Medical Devices
Job Description
Job Description
This is a remote position.
Job Title : Clinical Research Associate (CRA) Medical Devices
Location : Remote (Applicant should be willing to travel as needed)
Job Summary : As a Clinical Research Associate, you will be responsible for monitoring clinical trials, ensuring compliance with regulatory requirements, and supporting the development of medical devices from inception to market.
Your expertise will be vital in maintaining high standards of clinical research and patient safety.
Key Responsibilities :
Site Management :
- Conduct site selection, initiation, monitoring, and closure activities.
- Establish and maintain strong relationships with clinical sites and investigators.
Monitoring Activities :
- Perform regular site visits to ensure adherence to study protocols and regulatory guidelines.
- Review source documents and ensure accuracy of data entry into clinical databases.
Regulatory Compliance :
- Ensure compliance with Good Clinical Practice (GCP), Institutional Review Board (IRB) regulations, and other relevant standards.
- Prepare for and participate in regulatory inspections and audits.
Documentation :
- Maintain essential documents and study files in accordance with company policies and regulatory requirements.
- Assist in the preparation and submission of study-related documents to regulatory agencies.
Collaboration :
- Work closely with cross-functional teams, including clinical operations, data management, and biostatistics, to facilitate timely study progress.
- Provide training and support to site personnel regarding protocol and procedures.
Reporting :
- Prepare and present monitoring reports, addressing any issues and recommending corrective actions as needed.
- Track and manage study timelines and milestones.
Qualifications :
- Bachelor’s degree in life sciences, nursing, or a related field; advanced degree preferred.
- Minimum of 2 years of experience as a CRA, specifically within the medical device industry.
- Strong understanding of clinical trial processes, regulatory requirements, and GCP guidelines.
- Excellent organizational, communication, and interpersonal skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Proficient in Microsoft Office Suite and clinical trial management software.
Requirements
Preferred Qualifications :
- Experience with specific types of medical devices or technologies relevant to your company .
- Certification (e.g., ACRP, SOCRA) is a plus.
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