Associate Clinical Study Manager at Arthrex, Inc. in Naples, Florida

Job Description:

Requisition ID: 60230 Title: Associate Clinical Study Manager Division: Arthrex, Inc. (US01) Location: Naples, FL

**This position in based in Naples, FL**

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 Associate Clinical Study Manager 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 coordinate projects related to Arthrex-sponsored clinical research activities

Essential Duties and Responsibilities:

1. Provide accurate status reports and updates of assigned clinical research projects


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


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


4. Respond to site inquiries for study-related needs


5. Assist with site training for protocol, eTMF, and EDC for data collection clinical research initiatives


6. Facilitate preparation of pending clinical research projects for review in the global research review


7. Assist with monitoring of data collection compliance and communicate with sites to optimize data quality


8. Provide the main line of communication with research sites.


9. Assist and facilitate IRB approval at the site level and sponsor level


10. Assist with protocols, case report forms, and information packets for clinical studies


11. Assist with recruiting and qualifying investigators to conduct clinical research


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

Education and Experience:

• 
  
  • Familiarity with orthopedic terminology is preferred
  
  
  • 2 years of relevant clinical research experience required
  
  
  • Bachelor's degree required
  
  
  • One year of industry sponsor or CRO employment preferred
  
  
  • Clinical Research Certification is preferred
  
  

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

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

An 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 studies and protocol development is preferred.

Machine, Tools, and/or Equipment Skills:

Experience in Microsoft Office, Clinical trial Electronic Data Capture systems, is required. Experience in the electronic trial master file and clinical trial management systems 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.