Job Description

Join to apply for the Clinical Research Associate II role at Artivion, Inc. Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas, and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For more information about Artivion, visit our website, Position Objective To independently manage and monitor all aspects of clinical trials at investigative sites, ensuring data accuracy and compliance with protocols, ICH-GCP guidelines, and applicable regulations, while demonstrating a deeper understanding of clinical research processes. Responsibilities Manage 10-15 study sites (class 2 - 3 products) from start-up to closure. Manage clinical monitoring visits individually and, in some cases, conduct site visits. Complete onsite and remote monitoring activities. Build and maintain strong relationships with study sites, including principal investigators and site staff. Provide support, training, and guidance to site personnel as needed. Communicate effectively to address queries, provide updates, and facilitate resolution of issues. Serve as the primary point of contact between the sponsor, investigational sites, and other stakeholders involved in the clinical trial. Prepare and review on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance. Develop and implement clinical research monitoring plans. Maintain knowledge of all regulations and guidelines pertaining to the conduct of clinical trials on human subjects. Ensure adherence to applicable regulatory requirements and guidelines from relevant authorities (ISO 14155 GCP, MDR, EU, FDA, and/or Local Regulations). Prepare site visit reports and correspondence for all visits conducted in accordance with the study. Follow-up with site to gauge progress on action items and assess needs to reinforce completion of those items. Update applicable tracking systems. Participate in study initiation and coordinate site activities from start-up. Conduct Site Selection Visits & Site Initiation Visits. Verify that investigators and research staff follow the approved protocol and all GCP procedures. Oversee the execution of the clinical trial protocol. Participate in the overall clinical study execution. Coordinate, conduct, and evaluate research activities. Identify problems, trends, and react to resolve issues quickly with effective solutions. Participate in quality assurance activities to ensure compliance with company standards, industry regulations, and best practices, including participating in audits/inspections, training sessions, and process improvements such as CAPA execution. Ensure proper transmission of clinical case data to data management centers; review case report queries and problems, and clarify or obtain changes as appropriate. Review queries and assist in resolving Data Clarification Forms (DCFs). Assist in the termination of clinical studies by identifying items and issues for review and follow-up. Coordinate and implement site close-out activities and generate site close-out reports. Conduct site Close Out Visits. Assist in supervising clinical studies in cooperation with Clinical Research Associates III, IV, Data Managers, Project Managers, and other Clinical Affairs team members. Qualifications BA/BS/BSc in a scientific or healthcare-related field. (MSc, a plus) Minimum of 2 years of on-site monitoring experience. In-depth knowledge of monitoring, ICH-GCP guidelines, and FDA regulations. Ability to work independently with strong strategic thinking skills. Able and willing to travel. Able and willing to work from a designated and appropriate home office. Possession of a full driver's license. Preferred Experience Cardiology and/or Cardiovascular therapeutic area experience. Experience in medical device clinical studies and ISO 14155 knowledge. Seniority level Entry level Employment type Full-time Job function Health Care Provider Industries Hospitals and Health Care #J-18808-Ljbffr Artivion, Inc.

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