Field Clinical Research Associate - Device

Gforce Life Sciences • Phoenix, AZ

392d

About The Position

The Field Clinical Research Associate (FCRA) - Device is responsible for monitoring clinical studies at various sites to ensure compliance with regulatory requirements and Good Clinical Practice. This role involves site initiation, periodic monitoring, and close-out visits, ensuring that all clinical projects adhere to protocols and standards. The FCRA will collaborate with study teams, train site personnel, and mentor less experienced team members while demonstrating strong communication skills with both internal and external stakeholders.

Requirements

• Bachelor's degree from an accredited university or college, preferably in natural science, pre-medicine, nursing, bioengineering, or a related field.
• Minimum five years of clinical research experience.
• Strong written and verbal communication, interpersonal, presentation, analytical, and organizational skills.
• Ability to interpret basic clinical data and meet deadlines.
• Basic personal computer skills, including familiarity with word processing software and relevant clinical applications.
• Ability to work independently and function within a dynamic, global team environment.

Nice To Haves

• Prior clinical monitoring experience.
• Familiarity with cardiac, vascular, and/or neuromodulation technologies.
• Experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment.
• Certification by an industry-recognized professional society (e.g., SoCRA or ACRP).

Responsibilities

• Monitor clinical studies at assigned sites to ensure compliance with regulatory requirements and Good Clinical Practice.
• Review data and source documentation from investigational sites for accuracy and completeness.
• Ensure adverse events and protocol deviations are reported efficiently.
• Report device complaints and malfunctions according to company policies and procedures.
• Resolve problems and facilitate resolution of issues at clinical sites.
• Coordinate with study teams and field clinical engineers to enroll sites in clinical studies.
• Facilitate enrollment of study subjects via site coordinators.
• Promptly report findings of monitoring visits according to company processes.
• Collaborate with in-house teams for complete submission of study documents.
• Participate in conference calls and training sessions.
• Train site personnel to ensure compliance with study protocols and local regulations.
• Mentor less experienced clinical team members as requested.

Benefits

• Medical
• Dental
• Vision
• 401k

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree