Clinical Research Specialist - IDE

**This position in based in Naples, FL. Remote optional for the right candidate. If remote, travel required to Naples headquarters quarterly for 1 week**

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:  

Assists the study team in running the day-to-day operational activities of clinical studies.  

Essential Duties and Responsibilities: 

• Manage Investigational Device Exemption (IDE) clinical research studies. 
• Evaluates and analyzes clinical data. 
• Responsible for maintaining Electronic Trial Master (eTMF) filing and Electronic Data Capture (EDC) systems, securing essential documents and quality checking files and the EDC for accuracy and completeness. 
• Responsible for securing essential vendor documents for assigned clinical studies to assist in establishing accounts in A/P system within compliance guidelines 
• Responsible for establishing accounts in billing systems within compliance guidelines and issuing payments to vendors and investigators according to executed agreements.  
• Lead clinical trial agreement negotiations to ensure efficient and timely processing of clinical trial agreements 
• Lead clinical budget negotiations for the purpose of executing a clinical study  
• Tracks study status, enrollment, regulatory documentation, site start up status and communicates status with the study sites. 
• Track and report on the progress of assigned clinical studies, including budget and timelines.  
• Responsible for ordering, distributing and receiving investigational 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. 
• Oversee data collection compliance via tracked milestones  
• Orders, distributes and tracks study supplies and assists the study team in developing study related documents. 
• Maintains all pertinent study correspondences between the sponsor, study sites and third parties.  
• Develops clinical research standard operating procedures and work instructions. 
• Leads Investigational site training and meetings.  
• Identify and mitigate quality risk and/or issues associated with assigned studies/activities.  
• Assist site coordinators with IRB submissions as necessary. 
• Ensure operational aspects of the studies being conducted in accordance with all relevant ethical and government standards, GCP’s and Standard Operating Procedures. 
• Keep management and Arthrex stakeholders informed on progress of assigned clinical study metrics and other project related information. Specifically, costs, timelines, milestones, and other pertinent metrics.  

Education and Experience:  

• Bachelor’s degree required. 
• Four year clinical research experience required.  
• Pre-market IDE or IND study experience required. 
• One year of industry sponsored or CRO employment required  

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 in one year. 
• Comprehension of medical terminology, or can reference literature for understanding.  
• Proficient software skills: Word/ Excel/ Power Point/database. 
• A combination of education, experience and RA influence may be considered.  

Machine, Tools, and/or Equipment Skills: 

• PC, database, research tools, internet research tools. 

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.