Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Research Agreement Specialist. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.
Supports research and liaises with the legal team to facilitate research agreements. Reviews processes, updates, and metrics for the Orthopedic Research department. Facilitates research study budget development and negotiation and manages the lifecycle of department agreements.
Essential Duties and Responsibilities:
Liaison between Arthrex Legal and Research for all department-related Study Agreements, NDA’s Service Agreements, etc to facilitate the contracting process as well as seeking continuous process improvements.
Supports the Legal team with required supporting documentation from Research to facilitate the contracting process
Knowledgeable in departmental process and study-related documentation that impact research agreements, regarding clinical trials and biomechanical study documents (e.g. protocol, informed consent, budget, etc.), institutional policies and procedures, and applicable federal, state, and local research regulations.
Prepares and negotiates research study budgets with sites according to institutional fair market value guidelines. Independently review budget revisions proposed by sites and revise based on practices and procedures.
Develops biomechanical and clinical research agreement exhibits to include approved study products and loaners.
Leads and supports internal audits and processes of contract payments, vendor account set-up, and research payment reporting.
Partners with internal stakeholders to provide accurate and timely research contracts-related information and documents. Provides metrics to support institutional initiatives, reviews, and audits.
Follows established processes pre- and post-execution to ensure metrics and tracking, compliance, document harmonization, and timely execution of research contracts.
Responsible for maintaining agreement lifecycle information accurately in the department database, running reports and metrics as requested.
Supports institutional initiative to ensure research collaborators receive required training upon execution of research agreement.
Consults with stakeholders and partners to solve simple and complex problems related to research study contracts and applies knowledge of applicable regulations, internal policies and procedures, and logistics requirements of conducting research.
When appropriate, raises contract issues and liaise between Arthrex Legal department, research teams, and other internal stakeholders to resolve such issues.
Develops positive working relationships with study teams, legal department, physicians, sites, vendors, hospital departments, other internal stakeholders, and external entities in order to drive an efficient budget negotiation and support the contracting process.
Employs project management principles, problem-solving, and independent prioritization in order to effectively manage high volume pending contract caseload.
Maintains a library of vendor-related contracts and agreements.
Responsible for research agreement-related work instructions and processes.
Reviews business needs relating to research to meet the business requirements with supporting metrics for objective decision-making.
Education and Experience:
Bachelor’s degree required in healthcare, business administration, life science or research-related field is required
Three years of experience working with clinical and/or biomechanical research is required
Three years experience working with legal agreements and contracts, preferably in biomedical research, healthcare/medical programs and services, private research institution, and/or within a federal agency
Previous study budget negotiation experience is required
Related experience in medical device or pharmaceutical industries preferred
Experience in research ethics, research regulations, and guidelines, including the Sunshine Act, is required
Experience using contract management systems preferred
Experience and comfort in a high-volume, face-paced environment is essential
Familiarity with fair market value tools
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Strong verbal and written communication skills
Strong organizational and administrative skills, including attention to detail
Flexible and adaptable to shifting deadlines and priorities
Strong time management skills with the ability to multi-task in a highly time-sensitive environment
Ability to interact professionally with internal and external stakeholders
Ability to understand clinical trials and biomechanical study documents (e.g., protocol, informed consent, budget, etc.)
Strong contract analytic and negotiation skills
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, exercise independent judgment, and to collaborate in a group setting
Strong Analytical skills
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.
Arthrex is a global medical device company and leader in research, new product development and medical education in orthopedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year that support all aspects of orthopedics. The Orthopedic Research department based in Naples; includes a team of clinical, biomaterials and biomechanical professionals. Arthrex is actively searching for a Clinical Research Specialist to join the Orthopedic Research department. The successful candidate will work alongside the team organizing and overseeing research studies to contribute to advances in the medical community. Experience as a clinical research professional and knowledge of clinical regulatory regulations is required. Excellent communication and analytical skills, and a bachelor’s degree in a related field are required for success in this position. Clinical Research Professional certification is also strongly encouraged. Come join our growing talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.