Field Clinical Affairs Specialist

3 weeks ago

Dallas, United States BlueWind Medical Full time

The Field Clinical Affairs Specialist (FCAS) has the equivalent job description of the Field Clinical Specialist (FCS) in addition to clinical research site management activities at assigned sites for the conduct of clinical research studies in compliance with applicable regulatory standards.


This role is part of a multidisciplinary team working together with Clinical Affairs, Regulatory Affairs & Quality Assurance, and the Research and Development team to support BlueWind Medical strategic plans. The position works in conformance with Company Quality System requirements and Company Standard Operating Procedures to ensure that development and clinical study activities are conducted in conformance with regulatory requirements.


  • Assists clinicians in performing BlueWind Medical procedures, provides procedural and technical support of clinical study activities and clinical expertise
  • Collaborates with Clinical and Medical Affairs to provide education to investigators, research staff and institution personnel at clinical trial sites and
  • Serves as a technical conduit between customers and BlueWind Medical.
  • Participates in activities for site identification, selection and qualification
  • Assists FCS Manager with facilitation of contracts/budgets/investigator agreements as needed
  • Participates in site initiation and ongoing training and education of coordinators, physicians and support staff as necessary
  • Educational support of clinical sites to include the development and presentation of training and marketing tools for all clinical activities
  • Responsible for driving enrollment to achieve company goals for clinical studies
  • Interacts with in-house clinical, quality, medical, operations, regulatory, and R&D teams as needed to keep information updated on site dynamics, enrollment and study needs


Education/Qualification Requirements

Bachelor’s degree in Nursing, Sciences, Bio-Medical Engineering, related field or equivalent healthcare experience.


Experience Requirements

Minimum 2 years experience as Field Clinical Specialist in medical device. (FCAS)

1 year Clinical research experience (FCAS)


Other requirements (computer skills, languages knowledge etc.)

Fluent in English

Proficiency with all Microsoft Programs

Familiarity with Operating Room procedures

Strong project management capabilities

Ability to work independently and on cross-functional teams

Knowledge of ICH and GCP guidelines

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