Clinical Research ociate CRA - Medical Devices
Clinical Research ociate CRA - Medical Devices
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1-3years
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
This is a remote position.
Job Title: Clinical Research ociate (CRA) Medical Devices
Location: Remote (Applicant should be willing to travel as needed)
Job Summary: As a Clinical Research ociate 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.
- Elish and maintain strong relationships with clinical sites and investigators.
- Conduct site selection initiation monitoring and closure activities.
Monitoring Activities:
- Perform regular site visits to ensure adherence to study protocols and regulatory guidelines.
- Review source doents and ensure accuracy of data entry into clinical databases.
- Perform regular site visits to ensure adherence to study protocols and regulatory guidelines.
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.
- Ensure compliance with Good Clinical Practice (GCP) Institutional Review Board (IRB) regulations and other relevant standards.
Doentation:
- Maintain essential doents and study files in accordance with company policies and regulatory requirements.
- ist in the preparation and submission of studyrelated doents to regulatory agencies.
- Maintain essential doents and study files in accordance with company policies and regulatory requirements.
Collaboration:
- Work closely with crossfunctional teams including clinical operations data management and biostatistics to facilitate timely study progress.
- Provide training and support to site personnel regarding protocol and procedures.
- Work closely with crossfunctional teams including clinical operations data management and biostatistics to facilitate timely study progress.
Reporting:
- Prepare and present monitoring reports addressing any issues and recommending corrective actions as needed.
- Track and manage study timelines and milestones.
- Prepare and present monitoring reports addressing any issues and recommending corrective actions as needed.
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 ss.
- Ability to work independently and collaboratively in a fastpaced 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.
Preferred Qualifications: Experience with [specific types of medical devices or technologies relevant to your company]. Certification (e.g., ACRP, SOCRA) is a plus.
Employment Type
Full Time
