Clinical Research Specialist
Posted on: January 16, 2022
Requisition ID: 48874 - Title: Clinical Research Specialist -
Investigator Initiated - Division: Arthrex, Inc. (US01) - Location:
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---.
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:
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
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
Assist site coordinators with IRB submissions as necessary.
Shows initiative to identify and implement ways to improve jobs and
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.
Education and Experience:
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
Knowledge and Skill Requirements/Specialized Courses and/or
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.
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.
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.
Keywords: Arthrex, Cape Coral , Clinical Research Specialist, Healthcare , Naples, Florida
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