- Participates in overall department strategy to provide clinical data needed for regulatory submissions, publication, and supporting clinical site coordinators.
- Manage Investigator-Initiated clinical research studies.
- Evaluates and analyzes clinical data.
- Collaborate with key opinion leaders to identify issues or barriers related to the research request execution.
- Lead required cross-functional research meetings to discuss studies and get input from product managers.
- Track and report on the progress of assigned clinical studies, including budget and timelines.
- Identify and mitigate quality risk and/or issues associated with assigned studies/activities.
- Responsible for securing essential vendor documents for assigned clinical studies to assist in establishing accounts in the A/P system within compliance guidelines.
- Manage data collection compliance via tracked milestones.
- Responsible for the execution of clinical projects while adhering to budget, scope and schedule requirements.
- 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.
- Assist site coordinators with IRB submissions as necessary.
- Shows initiative to identify and implement ways to improve jobs and surroundings.
- Ensure operational aspects of the studies being conducted in accordance with all relevant ethical and government standards, GCP's and Standard Operating Procedures.
- Maintain a high level of professional expertise through familiarity with scientific literature and product portfolio.
- Demonstrate excellent organizational, decision-making, and time management skills in a fast-paced environment. Build and maintain excellent working relationships with clinical site staff, key opinion leaders and colleagues.
- Bachelor's degree required.
- Familiarity with orthopedic terminology is preferred
- 4 years of relevant clinical research experience required
- One year of industry sponsored or CRO employment preferred
- Clinical Research Certification is required or obtains in one year.
- 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)
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Clinical Research Specialist - Naples, United States - Arthrex, Inc.
Description
Requisition ID: 59790 Title: Clinical Research Specialist - Investigator Initiated Division: Arthrex, Inc. (US01)Location:
Naples, FL
This position in based in Naples, FL. Relocation assistance available.
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:
To collaborate with clinical site coordinators on Investigator-Initiated clinical research studies from site start-up to the last follow-up visit.
Essential Duties and Responsibilities:
Education and Experience:
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Strong 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 instruments necessary to perform the procedure is preferred.
Attention to detail and the ability to review protocols and agreements for accuracy are required.The ability to work as a team and contribute to the goals of the group, department, and company is required.
Machine, Tools, and/or Equipment Skills:
Experience in Microsoft Office is required. Experience with clinical trial databases (EDC, CTMS, eTMF) is required.
Reasoning Ability:
Ability to prioritize and manage multiple tasks. Ability to solve problems and deal with numerous variables.
High attention to detail and the ability to edit documents.
Arthrex 2023 Benefits
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.
