To develop, coordinate and facilitate activities related to the conduct of Arthrex sponsored clinical research and lead projects related to investigator initiated research.
Essential Duties and Responsibilities:
Initiate clinical research for Arthrex sponsored studies
Contribute to the development and implementation of clinical protocols, informed consent forms, and study-related materials for clinical studies
Assist in Site initiation activities (e.g. study start-up documentation preparation)
Responsible for IRB communication including document preparation and submission of Arthrex study initiatives.
Assist in implementing modifications to optimize protocol results or edit/amend study documentation if necessary
Maintain appropriate monitoring and maintenance of Sites in approved clinical studies to ensure the overall successful conduct of assigned clinical studies
Utilize Arthrex EDC (SOS) for specific clinical research initiatives to conduct training of Site and/or staff
Monitoring Site data collection
Set-up and maintain accurate progress and Site study status tracking logs to provide reports and updates of assigned clinical research projects
Oversee follow-up and lead query resolution with Sites via ongoing interactions
Participation in investigator meetings, Site initiation, monitoring and close out visits when applicable
Identify and mitigate quality risk and/or issues associated with assigned studies/activities
Facilitate appropriate documentation to maintain compliance with the Finance and Compliance departments
With oversight, may prepare clinical study budgets
Responsible for the timely completion of deliverables inclusive of analysis of large data sets/spreadsheets using excel or other applications for interim study status reporting to meet Arthrex and research goals
Facilitate efficient utilization of available clinical data, addressing needs of internal and external stakeholders (e.g. publications)
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
5 years relevant clinical research experience required. Preferably, in a medical device industry environment.
Familiarity with orthopedics and medical terminology is advantageous
Strong research and technical writing skills and ability to review protocols and agreements for accuracy
Ability to organize and manipulate large data sets
Proficiency in Microsoft Office programs
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Ability to work in a team, good communication, documentation, and strong understanding of data collection and analytical processes are required.
A basic ability to identify a research hypothesis and proposed outcomes measures to address the hypothesis is a plus.
The ability to read a surgical technique and have a basic understanding of the instruments necessary to perform the procedure is beneficial.
Able to communicate effectively with physicians, key opinion leaders, and other health care personnel.
Must have understanding of institutional, state, and federal regulations relating to clinical studies and Good Clinical Practice (GCP)
Machine, Tools, and/or Equipment Skills:
Computer experience in Microsoft Office is required
Internal Number: 42228
About Arthrex, Inc.
We are a global medical device company and leader in new product development and medical education in orthopaedics. With a corporate mission of helping surgeons treat their patients better, Arthrex has pioneered the field of arthroscopy and developed more than 7,500 innovative products and surgical procedures to advance minimally invasive orthopaedics worldwide.
Arthrex continues to experience unprecedented growth and demand for our products throughout the world; however, we remain a privately-held company with a family business culture that is committed to delivering uncompromising quality to the healthcare professionals who use our products, and ultimately, the millions of patients whose lives we impact.
Arthrex’s corporate headquarters is located in Southwest Florida. Additional locations include a global division in Munich, Germany as well as several subsidiaries and distribution centers throughout the Eastern and Western Hemispheres.
Eastern Hemisphere: Germany, France, Belgium, Austria, England, Switzerland, Sweden, Netherlands, Denmark, Poland, Spain, China, Korea and Japan.
Western Hemisphere: Arthrex Manufacturing, Inc.; Arthrex California, Inc.; Arthrex Califo...rnia Technology; Arthrex Iberoamerica; and Arthrex Canada.
We invite you to learn more about Arthrex and the positive contributions we are making to medicine and the communities we serve by visiting our website.