Clinical Research - Investigator
Company: Cypress HCM
Posted on: January 15, 2022
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
Keywords: Cypress HCM, Cape Coral , Clinical Research - Investigator, Healthcare , Naples, Florida
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