Clinical Research Associate (CRA) - Medical Devices Job at Cedent Consulting Inc, Dallas, TX

RTdlZENBV0FMR1lSem1Meno0cStmM3BxQ0E9PQ==
  • Cedent Consulting Inc
  • Dallas, TX

Job Description

This is a remote position.

Job Title: Clinical Research Associate (CRA) – Medical Devices

Location: Remote (Applicant should be willing to travel as needed)

Job Summary: As a Clinical Research Associate, you will be responsible for monitoring clinical trials, ensuring compliance with regulatory requirements, and supporting the development of medical devices from inception to market. Your expertise will be vital in maintaining high standards of clinical research and patient safety.

Key Responsibilities:

  • Site Management:

    • Conduct site selection, initiation, monitoring, and closure activities.
    • Establish and maintain strong relationships with clinical sites and investigators.
  • Monitoring Activities:

    • Perform regular site visits to ensure adherence to study protocols and regulatory guidelines.
    • Review source documents and ensure accuracy of data entry into clinical databases.
  • Regulatory Compliance:

    • Ensure compliance with Good Clinical Practice (GCP), Institutional Review Board (IRB) regulations, and other relevant standards.
    • Prepare for and participate in regulatory inspections and audits.
  • Documentation:

    • Maintain essential documents and study files in accordance with company policies and regulatory requirements.
    • Assist in the preparation and submission of study-related documents to regulatory agencies.
  • Collaboration:

    • Work closely with cross-functional teams, including clinical operations, data management, and biostatistics, to facilitate timely study progress.
    • Provide training and support to site personnel regarding protocol and procedures.
  • Reporting:

    • Prepare and present monitoring reports, addressing any issues and recommending corrective actions as needed.
    • Track and manage study timelines and milestones.

Qualifications:

  • Bachelor’s degree in life sciences, nursing, or a related field; advanced degree preferred.
  • Minimum of 2 years of experience as a CRA, specifically within the medical device industry.
  • Strong understanding of clinical trial processes, regulatory requirements, and GCP guidelines.
  • Excellent organizational, communication, and interpersonal skills.
  • Ability to work independently and collaboratively in a fast-paced environment.
  • Proficient in Microsoft Office Suite and clinical trial management software.


Requirements

Preferred Qualifications:

  • Experience with [specific types of medical devices or technologies relevant to your company].
  • Certification (e.g., ACRP, SOCRA) is a plus.


Job Tags

Contract work, Remote job,

Similar Jobs

Amazon Data Services, Inc.

Cable Installation Technician, Infra - GND, GND Cabling Team Job at Amazon Data Services, Inc.

 ...were the people who keep the cloud running. We support all AWS data centers and all of the servers, storage, networking, power, and...  ...implementing large enterprise equipment Installing Fiber and Copper cabling and patching cabling between equipment Ensuring proper... 

Montana Conservation Corps

Expedition Leader Job at Montana Conservation Corps

GAIN PROFESSIONAL JOB SKILLS, CONTRIBUTE TO CLIMATE RESILIENCE, AND MENTOR THE NEXT GENERATION OF LAND STEWARDS! The Montana Conservation Corps (MCC) is currently looking for Expedition Crew Leaders! We focus on the growth of our participants, transferable job skills,...

SGS Consulting

Salesforce Administrator Job at SGS Consulting

 ...Job Responsibilities: Support integration between Salesforce and external systems (e.g., billing portals) using REST APIs Assist with data migration efforts using tools like Data Loader, Workbench, or ETL platforms Build and maintain custom reports and dashboards... 

Sephora

Beauty Advisor Job at Sephora

Sephora is seeking a Part-Time Beauty Advisor in Mt. Juliet, USA. This role involves delivering personalized beauty consultations, staying ahead of trends, and driving sales in a collaborative environment. Candidates should have beginner-level experience in retail or a... 

State of Illinois

Director of Performance & Organizational Development (SPSA Opt. 1) Job at State of Illinois

 ...State of Illinois. The Department of Innovation & Technology (DoIT) is seeking to hire a Director of Performance & Organizational Development to serve as a strategic partner and second seat to the Chief Operating Officer (COO). This position focuses on monitoring...