Clinical Research Associate
4 weeks ago
Clinical Research Associate Role
Cedent Consulting Inc is seeking a skilled Clinical Research Associate to join our team in the medical devices industry. 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.
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.
Requirements:
- 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.
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