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 an Internal Clinical Research Associate 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. Come join our growing talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective:

Assists the study team in running the day-to-day activities of clinical studies. Maintaining appropriate internal clinical study documentation and provides support for the clinical operational activities.

Essential Duties and Responsibilities:

• Coordinates and implements activities essential to the successful tracking of approved research projects and updates Global Grants Committee decisions on supported research projects in the Orthopedic Research department database.
• Responsible for maintaining Electronic Trial Master (eTMF) filing) systems, securing essential documents and quality checking files for accuracy and completeness.
• Sends all acceptance/ modification/ rejection communications to the Arthrex Initiated Research requestors upon decision of internal stakeholders.
• Coordinates incoming Arthrex Initiated Research Requests for completeness and communicates information gaps with requestor to assure all elements are addressed for timely project approval review of proposals.
• Responsible for securing essential vendor documents for assigned clinical studies
• Responsible for establishing accounts in billing systems within compliance guidelines and issuing payments to vendors and investigators according to executed agreements.
• Responsible for ordering and distributing study 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.
• Responsible for maintaining database of all Arthrex-initiated study proposals, including the project approval process, HCP budget reviews, study report submission, and publication tracking.
• Coordinates the development and updating of clinical research training guides, standard operating procedures, and work instructions.
• Coordinates investigator meetings.
• Keeps management and Arthrex stakeholders informed on progress of assigned clinical study metrics and other project related information, specifically: project approvals, publication status, costs, timelines, milestones, and other pertinent metrics.

Education and Experience:

• Bachelor’s degree required.
• One-year clinical research, healthcare, medical manufacturing, or other relevant business experience required.
• One-year clinical research experience preferred
• Sponsor or CRO level experience preferred
• Familiarity with orthopedic terminology preferred

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 obtained within one year.
• Comprehension of medical terminology or can reference literature is for understanding is preferred
• Proficient software skills: Word/ Excel/ PowerPoint/database.

Machine, Tools, and/or Equipment Skills:

PC, database, research tools, internet research tools.

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.