Clinical Research Associate (Minneapolis)

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 :

Bachelors 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