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Clinical Research Specialist at Arthrex, Inc.

Posted in Education 30+ days ago.

Type: Full-Time
Location: Naples, Florida





Job Description:


















Requisition ID: 47407 
Title: Clinical Research Specialist 
Division: Arthrex, Inc. (US01) 
Location: Naples, FL

 

 

 

 


Main Objective:

To facilitate and lead 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 data report creation to meet Arthrex and researcher goals

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

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

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

  6. Audit potential research investigators to maximize Arthrex clinical research efforts

  7. Respond to site inquiries for study related needs

  8. Site training for data collection clinical research initiatives

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

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

  11. Provide the main line of communication with research sitesFacilitate IRB approval at the site level

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

  13. Recruit and qualify investigators to conduct clinical research

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

 

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

 

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.

 


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.

 





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