Brighton, Michigan
Clinical Research Associate Job Opening in Brighton, Michigan - If you are passionate about innovation and want to be part of the development and manufacturing of a novel platform of minimally invasive surgical instruments, please continue reading....
FlexDex Surgical Inc. () is a highly innovative medical device company located in Brighton Michigan, just north of Ann Arbor. We are developing next generation of minimally invasive surgical instruments based on an advanced mechanical engineering technology utilizing simple and affordable designs. We believe every surgical instrument should work like the surgeon?s our own hand; effortlessly transforming instinct into action. To improve patient care everywhere, we believe cost and complexity must be avoided. FlexDex instruments will be available in any OR, anywhere in the world, any time of day.
Our team is looking for a Clinical Research Associate with specific strengths in:
Developing relationships with KOL surgeons and health care professionals.
Development of clinical research strategies that support sales and marketing with clinical proof of product safety, patient benefits and healthcare economics.
Biomedical science literature and data base research
We are looking for a professional to assume the following responsibilities:
Work with surgeons to develop post market clinical research protocols
Prepares clinical protocol, clinical brochure, case report forms, informed consents, and other required documents for clinical studies.
Identifies and qualifies clinical investigators and clinical sites.
Assist principle investigators in IRB preparation, presentation and submission
Create and maintain clinical project documents including detailed project plans
Reviewing study case report forms (CRFs) completed by the investigative sites, and verifying entries by validating accurate source documentation to support CRF entries
Documenting site visits and issues in reports and follow-up letters to the site
Tracks study progress and manage clinical timelines and enrollment
Conduct literature reviews and market research to support clinical research and market intelligence
Create and maintain clinical research and market research data bases that support the Companies strategic planning process.
Develop a FlexDex procedure registry that will ultimately track all FlexDex cases
Assist clinical investigators in preparing presentations and writing abstracts and manuscripts for publication.
Participate in surgeon training programs to present clinical research results and clinical science related to our products and their surgical applications.
Particpate with R&D to capture surgeon feedback and shape future FlexDex innovation
Educational Requirements (minimum):
Bachelor?s degree in biomedical science or nursing
Experience Requirements:
4+ years? experience in clinical research
Strong knowledge of Good Clinical Practice (GCP) and regulatory (IRB) compliance guidelines for conducting clinical studies
Medical device and or Surgery experience a plus
Proficient knowledge of medical terminology
Computer skill competency (MS Office products, spreadsheets, power points, etc.)
Ability to work well within teams, build relationships
Leadership skills
Strong problem solving and critical thinking skills
Good prioritization and organizational skills, able to manage multiple tasks
Excellent oral and written communication
Positive outlook
Strong communication skills (efficient, effective, transparent)
Our values of working hard and with integrity combined with learning, growing and having fun make FlexDex a great place to work. Please reply with a detailed resume and design/development portfolio (if applicable). The company offers a competitive salary, benefits, and stock options, commensurate with the position.
Job Type: Full-time
Job Location:
Brighton, MI 48116
Required education:
Bachelor's
Required experience:
clinical research: 4 years
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