Our client, a global medical devices company is hiring a Clinical Research Specialist.
Title: Clinical Research Specialist
Location: Naples, FL (relocation assistance available)
Summary:
Our client 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™, they have 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.
The company 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:
To facilitate and lead projects related to Arthrex sponsored clinical research activities
Essential Duties and Responsibilities:
- Provide accurate status reports and updates of assigned clinical research projects
- Facilitate data report creation to meet Arthrex and researcher goals
- Facilitate appropriate documentation to maintain compliance with the AP and Compliance department
- Facilitate clinical contract agreements between Arthrex and the Site for Arthrex initiated studies
- Assist the data management team with electronic data capture systems CRF design, eTMF design, CTMS design and user testing for assigned studies
- Audit potential research investigators to maximize Arthrex clinical research efforts
- Respond to site inquiries for study related needs
- Site training for data collection clinical research initiatives
- 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
- Provide the main line of communication with research sites
- Facilitate IRB approval at the site level
- Create protocols, case report forms and information packets for clinical studies
- Recruit and qualify investigators to conduct clinical research
- Initiate site start-up activities for clinical research for Arthrex sponsored studies
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.
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)