Clinical Research Associate

Our client is a global provider of Class III Medical Devices and is looking for a Clinical Research Associate to join their team on a Contract basis (potential for contract to hire)!

This is a Contract to Hire opportunity which requires 45% travel throughout the United States.

The Clinical Research Associate supports the successful execution of clinical trials, ensuring adherence to regulations and sponsor guidelines

Key Responsibilities:

• Oversee study centers from initiation to completion, ensuring consistent protocol communication.
• Ensure regulatory compliance through site visits, documentation, and reporting.
• Collaborate on developing study materials, including informed consent forms, clinical reports, and protocols.
• Facilitate regulatory submissions, addressing additional information requests.
• Manage Trial Master Files and Clinical Trial Management Systems.
• Negotiate clinical trial agreements, contract amendments, and payment requests.
• Coordinate device supply and tracking at investigational sites.
• Maintain standard operating procedures and ensure departmental compliance.

Essential Requirements:

• Undergraduate degree in life sciences or related field
• 2+ years clinical research experience (Sponsor or Clinical Research Organization) with field monitoring

Desirable Qualifications:

• Post-baccalaureate degree
• Training in site management for clinical trials
• Certification as a CRA or Clinical Research professional
• Experience with regulatory affairs
• Experience with active implantable/Class 3 medical devices
• Clinical trial coordination experience in a clinic setting

Core Competencies:

• Strong organizational, recordkeeping, and problem-solving skills
• Excellent oral and written communication
• Ability to multitask with minimal supervision
• Solution-focused mindset
• Open to continuous learning
• Familiarity with regulatory guidelines (21 CFR, Canadian Medical Device Regulations, ISO 14155)
• Experience presenting study content at Investigator Meetings

This role requires 45% travel throughout the United States.

This is a contract opportunity with an hourly rate of $35-50/hour