
location_on577, Mallard Avenue, Durham, Durham County, North Carolina, 27701, United States
We are seeking an Experienced Device CRA 2 to lead and support our Medical Device & Diagnostics team. This role is ideal for a French-speaking professional with sponsorship to travel into Canada. Based in major US hub locations, you will operate in a fast-paced environment where precision is paramount; deviations from the study protocol are not permitted, and timelines are critical to maintaining quality.
In this position, you will utilize your clinical judgment to provide a high standard of care for participants in clinical trials and respond to emergency situations. You will manage all aspects of study site monitoring, from routine visits and pre-study initiation to close-out activities. Your day-to-day involves ensuring study staff are properly trained, verifying informed consent procedures, and maintaining the integrity of data submitted on Case Report Forms. You will also handle Serious Adverse Event (SAE) reporting, query generation, and registry management. As a key team member, you may assist in training new employees and act as a local client contact for designated projects.
Success in this role requires adaptability to constantly changing priorities and strong people skills to ensure studies run smoothly. The work is heavily technology-based, with data collected directly into electronic environments. While the role is designated as remote (#LI-Remote), it involves significant travel (60-70%), requiring 7-9 days of site visits per month. You will work in an office environment with exposure to electrical equipment and must be comfortable operating a vehicle safely for frequent domestic and international travel to client sites.
Applications are accepted on an ongoing basis. We are committed to fostering a diverse and inclusive workplace. For more information regarding our Equal Employment Opportunity (EEO) policies and accommodation requests, please visit our official EEO & Accommodations page.
Work model: On-site
577, Mallard Avenue, Durham, Durham County, North Carolina, 27701, United States
Durham, North Carolina
Skills: French, Nursing Licensure, Clinical Monitoring, Informed Consent Procedures, Protocol Requirements, Regulatory Requirements, Case Report Forms, Source Document, Serious Adverse Event Reporting, CRF Review.
Education: University or college degree in a related allied health profession.