The Clinical Research Associate III (CRA III) will be responsible for the day-to-day operations associated with the execution of clinical trials and monitoring the clinical trial sites to ensure they are complying to the applicable study protocol, Standard Operating Procedures (SOPs), CVRx requirements, Good Clinical Practice (GCP), and the applicable regulatory requirement(s). The CRA III will work closely with the Clinical Study Manager to ensure site day-to-day operations and monitoring is executed to meet project deliverables. CRA III is expected to work from the CVRx office, or at the sites when monitoring.
Key Duties and Responsibilities

• Develops and maintains successful working relationships with study sites and CVRx field staff
• Assists in preparation of study materials and training of investigators, center staff and CVRx field staff.
• Processes payments to sites, vendors, and consultants
• Supports Clinical Centers in the execution of site IRB or ethics committee submissions.
• Responsible for the collection and tracking of required regulatory documents from Clinical Centers.
• Coordinates and conducts monitoring (as directed by the monitoring plan) at participating centers to ensure compliance with the protocol, regulations and the timely receipt of accurate data / other required study documents.
• Source verifies clinical data/information and oversees data correction to match source.
• Maintains Clinical Study files. Manages device accountability at site.
• Reviews clinical data/information and oversees data correction. Reviews center activation documentation.
• Assists in training of new Clinical Research Associates.
• Assists with successful conduct of assigned studies. This includes interfacing with representatives from key functional groups including Regulatory Affairs and Quality Assurance, Research & Development, U.S. Market Development, Commercial Development and Clinical Research Organizations.
• May participate on project teams. May assist in preparation of study materials.
• Reviews site monitoring documents and reports.
• Provides mentoring regarding site monitoring to internal team.

Education and Experience
Required:

• Bachelor's degree.
• 5+ years experience directly supporting clinical research or similar experience in a medical/scientific area.
• 2+ years experience in monitoring clinical trial sites.
• Knowledge of GCP's and regulatory compliance guidelines for clinical trials.
• Knowledge of medical terminology.

Preferred:

• Advanced degree in a related field is preferred.
• Advanced written and oral communications skills.
• Good problem-solving skills.
• Comfort in a small company. Understands the start-up environment.
• Adaptable and embraces change.
• Creative and resourceful. Strong attention to detail.
• High ethical standards and integrity. Entrepreneurial approach.
• Ability to operate independently. Team player with high performance standards.

Working Conditions

• Normal office conditions.
• Must be able to sit/stand/walk 8 hours per day.
• Position requires up to 70% travel domestically and internationally with extended overnight stays.

Job Type: Full-time

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