Requisition ID: 48554 Title: Clinical Research Associate Division: Arthrex, Inc. (US01) Location: 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 and includes a team of clinical, biomaterials and biomechanical professionals. Arthrex is actively searching for a Clinical Research Associate 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 and talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Assists the study team in running the day to day operational activities of clinical studies.
Essential Duties and Responsibilities:
- 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.
- Works closely with management to review and get approval of study agreements and site-specific budgets.
- Tracks study status, enrollment, regulatory documentation, site start up status and communicates status with the study sites.
- 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.
- Develop clinical research standard operating procedures and work instructions.
- Coordinates Investigational site training and meetings.
- 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.
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:
- Bachelor's degree required.
- Two-year clinical research experience required.
- Pre-market IDE or IND study experience preferred.
- Investigator-Initiated study experience preferred.
- Sponsor or CRO experience preferred.
- Familiarity with orthopedic terminology preferred.
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 obtains in one year.
- Comprehension of medical terminology or can reference literature for understanding preferred.
- Proficient software skills: Word/ Excel/ Power Point/database.
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.
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