Job Description

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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