Job Title: Clinical Research Associate
Department: Clinical Operations
Office Location: Remote, USA
Function:
The Clinical Research Associate is responsible for overseeing day-to-day operational aspects of assigned studies to ensure they are conducted in compliance with applicable regulatory requirements, study protocols, and company SOPs.
Responsibilities:
· Serve as the primary liaison for clinical sites, ensuring effective site management and communication.
· Conduct qualification, initiation, interim monitoring, and close-out visits according to the monitoring plan and applicable regulatory regulations.
· Verify that study data are collected, recorded, and reported accurately and in compliance with the protocol and Good Clinical Practice (GCP) guidelines.
· Identify and resolve site issues and protocol deviations in collaboration with the study team.
· Provide ongoing training and support to site staff to ensure adherence to study procedures and regulatory requirements.
· Maintain timely and complete monitoring documentation, including visit reports, follow-up letters, and tracking of action items.
· Assist with site selection, feasibility assessments, and contract/budget negotiations as needed.
· Participate in internal study team meetings and contribute to project planning and timeline management.
· Collaborate cross-functionally with data management, regulatory, safety, and other team members.
· Support audit and inspection readiness activities at sites and sponsor level.
Essential Experience:
· Bachelor’s degree in life sciences, nursing, or a related field.
· Minimum of 5 years of experience as a CRA, 2 years of medical device experience
· Demonstrated ability to manage clinical research activities at sites across multiple countries and regions outside the US
· Strong working knowledge of ICH-GCP, FDA regulations, and other relevant guidelines.
· Excellent written and verbal communication skills.
· Ability to work independently, manage multiple sites and priorities, and travel as required (30% travel expected).
· Proficiency with EDC systems and other clinical trial management tools.
Product Training Level:
· Customer Training Level
Desirable Experience
· Experience working with Class II and Class III medical devices
· Experience in a start-up company environment
· Experience working remotely from management team
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