Clinical Research Associate II

Company Overview:

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 additional information about Artivion, visit our website, www.artivion.com.

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.
• Manages clinical monitoring visits individually and in some cases, may conduct site visits.
• Completes 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.
• Ability to develop and implement clinical research monitoring plans.
• Knowledge of all regulations and guidelines pertaining to the conduct of clinical trials on human subjects.
• Ensuring adherence to applicable regulatory requirements and guidelines from relevant authorities. (ISO 14155 GCP, MDR, EU, FDA, and/or Local Regulations etc.)
• Prepare site visit reports and correspondence for all visits conducted in accordance with the study.
• Follows-up with site to gauge progress on any action items and assess needs to reinforce completion of those action items.
• Makes updates in applicable tracking systems.
• Participates in study initiation.
• Coordinates site activities from site start-up.
• Conducts Site Selection Visits & Site Initiation Visits.
• Participates in site selection.
• Verifies that the investigator and research staff follow the approved protocol and all GCP procedures.
• Oversee the execution of clinical trial protocol.
• Participate in the execution of the overall clinical study.
• Coordinate, conduct and evaluate research related activity.
• Recognize problems, trends and react to resolve issues quickly and to bring effective resolution.
• Participate in quality assurance activities to ensure compliance with company standards, industry regulations, and best practices. This may involve participating audits / inspections, training sessions, and process improvements such as CAPA execution.
• Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems and clarifies and/or obtains changes to data as appropriate.
• Review queries and assist in the resolution of Data Clarification Forms (DCFs).
• Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up.
• Coordinate and implement site close-out activities and generate site close-out report.
• Conduct site Close Out Visits.
• Assist in the supervision of 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 on medical device clinical studies and ISO14155 knowledge