Regional CRA � Medical Device

Regional CRA � Medical Device
  • $75 - $85 per Hour
    HOUR
  • Temporary to Hire
  • Austin TX, US Austin TRAVIS US 78758
Job Ref: JO000127403
Sector: Clinical
Sub-sector: Clinical
Date Added: 07 January 2022

At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow’s world.

Working as part of the SRG team, you will work with our client which are Pharmaceutical or Bio-Pharmaceutical companies to ensure work quality and accuracy for our client in the Bio Pharmaceutical Industry. The Clinical Research Associate is an integral part of the Clinical Affairs department who supports global clinical trials. The ideal candidate is a highly organized individual who demonstrates individual initiative and problem-solving capabilities. This person should be able to work independently and drive action items to completion with little oversight. Due to the nature of this role and interactions with key physicians and their site team, the individual will have a high level of professionalism and discretion.

Here’s What You’ll Do:

  • As a Clinical Research Associate, you will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
  • Monitor the progress of clinical studies (at investigative sites or remotely) and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements
  • Completes in source data verification in accordance with the Clinical Monitoring Plan
  • Demonstrates excellent knowledge of ICH/GCP
  • Displays ability to manage investigative sites to facilitate trial deliverables
  • Escalates issues appropriately, as needed
  • Conducts monitoring to confirm subject safety and data integrity
  • Describes and demonstrates the principals of IP accountability
  • Identifies scientific misconduct at the site level
  • Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms
  • Mentors CRAs new to the position or company
  • Serves as an observation visit leader
  • Conducts monitoring evaluation visits
  • Assists team lead in the development of trial tools or documents
  • Up to 80% Travel

Here’s What You’ll Bring to the Table:

  • Bachelor's degree in a science-related field and at least two (2+) years of experience monitoring clinical trial sites an equivalent combination of experience, education, and training
  • Experience in monitoring all trial components (SQV to COV)
  • Knowledge of ICH and local regulatory authority regulations regarding device studies

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

#LI-SH1 #LI-Remote

SRGTalent
31/01/2022 12:00:00
USD 75.00 85.00 Hour
Contact Consultant:
Shari Hulitt

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