To facilitate and lead research agreement development, negotiation, review, tracking, and closure within the Orthopedic Research department. Lead team members engaged in payments, account set-up, and research compliance reporting.
Essential Duties and Responsibilities:
Creates, reviews, revises, and negotiates simple and complex research-related contracts, including amendments, consistent with relevant clinical trials and biomechanical study documents (e.g. protocol, informed consent, budget, manuals, etc.), institutional policies and procedures, and applicable federal, state, and local research regulations.
Leads team members engaged in contract payments, vendor account set-up, and research payment reporting.
Follows established processes pre and post-execution to ensure metrics and tracking, compliance, document harmonization, and timely execution of research contracts.
Consults with stakeholders and partners to solve simple and complex problems related to research studies and applying knowledge of applicable regulations, internal policies and procedures, and logistics requirements of conducting research.
Facilitates the execution of research agreements and/or related requests. Serves as a liaison with the sites, institutions, and Arthrex Legal department to ensure research agreements are processed appropriately.
Employs project management principles, problem-solve and independently prioritize in order to effectively manage high volume pending contract caseload.
Develop positive working relationships with legal department, physicians, sites, vendors, hospital departments, other internal staff and external entities in order to drive contracting process toward final execution.
Independently review contract and budget revisions proposed by sites and revise based upon practices and procedures.
When appropriate, raise contract issues and liaise between Arthrex Legal department, research teams and other internal stakeholders to resolve such issues.
Management of research agreement templates and template amendments.
Responsible for research agreement related work instructions and processes.
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 in legal studies, healthcare, business administration, finance, accounting, or research-related field is required
Five years related experience required.
Three years experience in research contract administration required
Two years research agreement administration in a sponsor/manufacturer setting is preferred
Experience using contract management systems preferred
Experience in research ethics, research regulations and guidelines, including the Sunshine Act is required
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Strong verbal and written communication skills
Effective organizational and administrative skills, including attention to detail
Flexible and adaptable to shifting deadlines and priorities
Ability to communicate and manage project timelines and responsibilities
Ability to interact professionally with internal and external stakeholders
Ability to understand clinical trials and biomechanical study documents (e.g. protocol, informed consent, budget, manuals, etc.)
Ability to develop site budget templates with milestones within fair market value
Ability to manage high volume work and meet deadlines required
Ability to work independently and to collaborate in a group setting
Machine, Tools, and/or Equipment Skills:
Experience in Microsoft Office is required.
Advanced experience in Excel is required.
Experience in contract management systems is preferred.
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.
Internal Number: 48318
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.