Clinical Research Associate
PhagenesisMinneapolis, MN, United Statesjob_description.job_card.variable_days_ago
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job_description.job_card.job_descriptionBachelor’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. Customer Training Level Experience working with Class II and Class III medical devices Experience in a start-up company environment Experience working remotely from management team
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 :
Product Training Level :
Desirable Experience
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Clinical Research Associate • Minneapolis, MN, United States