Job description

** This position in based in Naples, FL. Relocation assistance available.* *

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™.

Main Objective:
To facilitate and lead projects related to Arthrex sponsored clinical research activities

Essential Duties and Responsibilities:
Provide accurate status reports and updates of assigned clinical research projects

Facilitate data report creation to meet Arthrex and researcher goals

Facilitate appropriate documentation to maintain compliance with the AP and Compliance department

Facilitate clinical contract agreements between Arthrex and the Site for Arthrex initiated studies

Assist the data management team with electronic data capture systems CRF design, eTMF design, CTMS design and user testing for assigned studies

Audit potential research investigators to maximize Arthrex clinical research efforts

Respond to site inquiries for study related needs

Site training for data collection clinical research initiatives

Facilitate preparation of pending clinical research projects for review in global research review

Monitor data collection compliance and communicate with sites to optimize data collection compliance

Provide the main line of communication with research sites

Facilitate IRB approval at the site level

Create protocols, case report forms and information packets for clinical studies

Recruit and qualify investigators to conduct clinical research

Initiate site start-up activities for clinical research for Arthrex sponsored studies

Education and Experience:
Familiarity with orthopedic terminology is preferred

4 years’ relevant clinical research experience required

Bachelor’s degree required

One year of industry sponsor or CRO employment required

Knowledge and Skill Requirements/Specialized Courses and/or Training:

Good communication, documentation, and record keeping skills are required.

A basic ability to identify a research hypothesis and proposed outcomes measures to address the hypothesis is required

The ability to read surgical techniques and have a basic understanding of the medical devices necessary to perform the procedure is preferred

Ability to organize and manipulate large data sets.

Experience managing research contracts and protocol development is preferred.

Arthrex 2023 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 or protected veteran status.

Nearest Major Market: Naples

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