Phagenesis
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
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