Assists the study team in running the day to day operational activities of clinical studies.
Essential Duties and Responsibilities:
Responsible for maintaining Electronic Trial Master (eTMF) filing and Electronic Data Capture (EDC) systems, securing essential documents and quality checking files and the EDC for accuracy and completeness.
Responsible for securing essential vendor documents for assigned clinical studies to assist in establishing accounts in A/P system within compliance guidelines
Responsible for establishing accounts in billing systems within compliance guidelines and issuing payments to vendors and investigators according to executed agreements.
Works closely with management to review and get approval of study agreements and site specific budgets.
Tracks study status, enrollment, regulatory documentation, site start up status and communicates status with the study sites.
Responsible for ordering, distributing and receiving investigational product.
Assists in user acceptance testing in the EDC and eTMF;evaluates new database updates
Assists with the preparation of technical reports, summaries, templates and protocols.
Oversee data collection compliance via tracked milestones
Orders, distributes and tracks study supplies and assists the study team in developing study related documents.
Maintains all pertinent study correspondences between the sponsor, study sites and third parties.
Develop clinical research standard operating procedures and work instructions.
Coordinates Investigational site training and meetings.
Keep management and Arthrex stakeholders informed on progress of assigned clinical study metrics and other project related information. Specifically, costs, timelines, milestones, and other pertinent metrics.
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.
Education and Experience:
Bachelor’s degree required.
Two year clinical research experience required.
Pre-market IDE or IND study experience required.
Sponsor or CRO experience required.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Knowledge of ICH guidelines and FDA Regulations relevant to clinical studies is required.
Clinical Research Certification is required or obtains in one year.
Comprehension of medical terminology, or can reference literature for understanding.
Proficient software skills: Word/ Excel/ Power Point/database.
Machine, Tools, and/or Equipment Skills:
PC, database, research tools, internet research tools.
PLEASE USE LINK BELOW TO APPLY ONLINE. ONLY CANDIDATES THAT SUBMIT ONLINE APPLICATIONS WILL BE CONSIDERED FOR EMPLOYMENT.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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.