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Clinical Research Associate

GForce Life Sciences

United States

Remote

USD 80,000 - 125,000

Full time

12 days ago

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Job summary

An established industry player in medical equipment manufacturing is seeking a Clinical Research Associate to coordinate clinical research activities. This exciting role involves ensuring compliance with regulatory standards while supporting the execution of controlled clinical studies. Ideal candidates will have a strong background in clinical research, particularly within the medical device sector, and possess excellent communication and project management skills. Join a dynamic team where your contributions will directly impact the success of innovative medical solutions, all while enjoying the flexibility of a remote work environment.

Benefits

Medical Insurance
Vision Insurance

Qualifications

  • 6+ years of clinical research experience, preferably in medical devices.
  • Strong knowledge of FDA regulations and clinical trial procedures.
  • Proficient in Microsoft Office Suite and clinical research technologies.

Responsibilities

  • Coordinate clinical research activities in compliance with GCP and FDA guidelines.
  • Prepare and manage technical documentation for clinical studies.
  • Conduct site visits and ensure regulatory compliance.

Skills

Clinical Research Experience
FDA Regulations Knowledge
Monitoring Experience
Communication Skills
Microsoft Office Proficiency
Project Management

Education

Bachelor's Degree
Life Sciences Degree

Tools

Electronic Data Capture
CTMS

Job description

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Associate MSP Recruiter at GForce Life Sciences

Clinical Research Associate

6 month contract

Remote - PST

Must be able to work on a W2

Job Summary

The Clinical Research Associate (CRA) is responsible for coordinating clinical research activities in accordance with ICH Good Clinical Practices (GCP), FDA guidelines, local regulations, and company SOPs. This role supports the execution of controlled clinical studies of medical devices and ensures regulatory compliance across all clinical activities.

Job Responsibilities

  • Assist in the implementation of controlled clinical studies of company products as a contributing project team member
  • Prepare, review, and manage technical documentation, including informed consents, study forms, and training materials
  • Collect and review site regulatory documents and manage device accountability processes
  • Conduct Site Initiation Visits and Closure Visits at clinical study sites
  • Interface with monitors and CROs to address and resolve queries
  • Collaborate with Project Managers to ensure protocol and regulatory compliance (e.g., GCP, FDA, SOPs)
  • Support clinical site budget and contract negotiations
  • Assist in writing clinical study reports by reviewing study data tables and listings
  • Ensure compliance with applicable laws and Quality Management System processes
  • Maintain high ethical standards and integrity across all responsibilities
  • Perform additional duties as assigned

Job Qualifications

Required:

  • Bachelor’s degree or equivalent combination of education and relevant experience
  • Minimum 6 years of direct clinical research experience, preferably in the medical device industry
  • At least 2 years of monitoring experience
  • Strong knowledge of FDA regulations and clinical trial procedures
  • Experience with clinical research technologies (e.g., electronic data capture, CTMS)
  • Excellent verbal and written communication skills
  • Proficient with Microsoft Office Suite

Preferred:

  • Bachelor’s degree in Life Sciences
  • Experience in neurovascular and/or cardiovascular therapeutic areas
  • At least 2 years of project management experience in the medical device industry
  • Demonstrated collaborative skills working with physicians, coordinators, and cross-functional teams
Seniority level
  • Seniority level
    Mid-Senior level
Employment type
  • Employment type
    Contract
Job function
  • Job function
    Research and Science
  • Industries
    Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

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