Assisting the study team in running the day to day operational activities of clinical studies. Assist in the development and maintenance of Electronic Trial Master File (eTMF) and Electronic Data Capture (EDC).
Essential Duties and Responsibilities:
Responsible for establishing and maintaining Electronic Trial Master filing systems, securing essential documents and monitoring files and databases for accuracy and completeness.
Responsible to perform clerical functions, maintain office / study supplies and equipment, and scanning and electronic filing.
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 clinical trial agreements and site specific budgets.
Tracks study status, enrollment, regulatory documentation and site start up status.
Assists in ordering, distributing and receiving investigational product.
Assists in user acceptance testing and evaluating new upgrades.
Assists with the preparation of technical reports, summaries, templates and protocols.
Supplying sites with study binders and assisting study team in developing source worksheets
Distributes updates to study sites.
Records, compiles and distributes minutes from team meetings.
Maintains all pertinent study correspondences between the sponsor, study sites and third parties.
Assists with review and completion of study standard operating procedures and work instructions
Coordinate research Investigator, Coordinator and monthly forum meetings and newsletters
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.
Machine, Tools, and/or Equipment Skills:
PC, database, research tools, internet research tools.
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 preferred.
Comprehension of medical terminology, or can reference literature for understanding. Proficient software skills: Word/ Excel/ Power Point/database /bibliography programs.
Education and Experience:
Requires a minimum of an Associate’s Degree. Bachelor degree preferred. Minimum one year clinical research experience in pre-market FDA studies required. Sponsor or CRO experience preferred
Arthrex is 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 10,000 innovative products and surgical procedures to advance minimally invasive orthopaedics worldwide.