Clinical Research Associate Medical Devices

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Job Description

Clinical Research Associate Medical Devices

Location: Dallas TX

Our client is a global medical device company. This is a Dallas TX-based role, no telecommuting. Office based when not traveling. Full time, W2.

Requirements

  • At least 3-5 years relevant industry experience in a clinical research environment
  • Approximately 50% travel that will vary over time.
  • Knowledge of and proficiency in spoken and written English is a MUST.
  • Minimum of medical/healthcare-related University degree with basic familiarity with medical terminology
  • Ability to foster professional relationships with clinical sites and colleagues
  • Ability to support several projects simultaneously, a flexible working style and attention to detail are essential
  • Able to work independently with excellent time management skills
  • Excellent work ethic with the desire to be a valuable contributing team member

Work Experience

  • At least 3-5 years relevant industry experience in a clinical research environment
  • Approximately 50% travel that will vary over time.

Field CRA Responsibilities

  • Conduct site qualification, initiation, monitoring and closeout visits and create documentation of such through accurate and detailed visit reports.
  • Monitor source documents to electronic data capture system for completeness and accuracy through verification of subject records and source documentation. Verify that all subjects meet inclusion/exclusion criteria
  • Review all source records for patient safety and ensure complete documentation of all subject safety events (100% source document verification).
  • Review regulatory binder to ensure complete, accurate, and up-to-date regulatory compliance at the site.
  • Ensure compliance with protocol and overall clinical objectives.
  • Train site personnel on study procedures and provide documentation of training. Ensure that study personnel are qualified by experience and training to perform assigned tasks.
  • Ensure investigator involvement in the study and Institutional Review Board/Ethics Committee oversight.
  • Follow through after visits to see that all outstanding requests/needs are fulfilled.
  • Raise issues of significance to the appropriate level for resolution.
  • Able to help site navigate informed consent issues and support Institutional Review Board approval process.Compilation of Regulatory Submissions
  • Assist in organizing documentation for regulatory submission, as needed
  • Create electronic copies of submitted documents
  • File all regulatory correspondence in the Regulatory Master File
  • Responsible for accurate and timely maintenance of both electronic and paper files
  • Set up and maintenance of the Regulatory Master File
  • Organize site study files
  • Work closely with other Company CRA’s for coverage in collecting and reviewing regulatory documentation, and assuring consistency between Regulatory Master File and site files.
  • Generate and maintain study checklists as necessary and keeps accurate records of all essential study material(s).
  • Responsible for accurate and timely oversight and maintenance of the Regulatory Master File.
  • Demonstrate expertise in understanding and managing clinical study documentation.
  • Proper and timely filing of all relevant study documents and standardized filing across all studies, per applicable Standard Operating Procedures.

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