Clinical Research Specialist

Naples, FL
United States

Category
Experience Required
Yes
Employment Type
Full-Time
Work Schedule
Full-Time

Job Description

Main Objective:

To facilitate and lead projects related to investigator initiated and Arthrex sponsored clinical research activities

 

Essential Duties and Responsibilities:

  1. Provide accurate status reports and updates of assigned clinical research projects
  2. Facilitate analysis of data and report creation to meet Arthrex and researcher goals
  3. Facilitate appropriate documentation to maintain compliance with the AP and Compliance department
  4. Facilitate grant/contract agreements between Arthrex and outside research entities for all supported research activities
  5. Utilize SOS for specific R&D clinical research initiatives
  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 utilizing the SOS platform for R&D clinical research initiatives
  9. 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
    • Coordination communication between the sites
    • Facilitate IRB approval at the site level
    • Create protocols, case report forms and information packets for clinical studies
    • Recruit investigators to conduct clinical research
  10. Initiate 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 orthopedics is advantageous
  • Experienced in record keeping using excel or other suitable programs
  • 4 years’ relevant experience required
  • Associate’s degree 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 a plus. 

The ability to read a surgical technique and have a basic understanding of the instruments necessary to perform the procedure is beneficial.

Ability to organize and manipulate large data sets.

Strong communication skills and ability to review protocols and agreements for accuracy.

Machine, Tools, and/or Equipment Skills:

Experience in Microsoft Office is required

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.