Senior CRA

1 week ago

Darwin, Northern Territory, Australia Pharmiweb Full time
Job Description

Barrington James is actively recruiting for a challenging role as a Clinical Research Associate (CRA II). As part of our clients in-house team, you will be responsible for site management, encompassing start-up activities both on-site and remotely across Italy. This role involves working on diverse projects from our client base, which includes small to mid-sized pharmaceutical, biotech, and medical device companies.

Main Job Tasks and Responsibilities:
  • Stay professionally updated on scientific, regulatory, and operational aspects relevant to assigned clinical projects.
  • Assist in site selection, evaluation visits, and initiation visits to ensure a smooth start-up process for investigation sites.
  • Conduct training for site staff on study procedures to ensure compliance with protocol and ICH-GCP standards.
  • Perform periodic monitoring visits, reviewing Case Report Form (CRF) accuracy, completeness, and quality.
  • Conduct source data verification and in-house review of clinical data, ensuring timely resolution of data queries.
  • Manage investigational products and trial materials, ensuring timely and correct supply to the site.
  • Collaborate with site staff for proper reporting of safety issues and ensure their timely resolution.
  • Conduct study termination activities, including archiving, to ensure the smooth completion of the project.
  • Act as the main contact for the site, ensuring close follow-up and addressing any issues promptly.
  • Provide general support to the Clinical Research Division for quality control of clinical data.
  • Promptly address any issues that can jeopardize the conduct of the clinical projects assigned.
  • Guide and supervise Clinical Research Associate I (CRA I) to coach and train them on the job.


Education and Experience:
  • University Degree in scientific, medical, or paramedical disciplines.
  • Previous proven experience as a CRA, with on-site monitoring activities.
  • Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other regulatory requirements.


Specific Role Requirements and Skills:
  • Fluent in English.
  • Proficiency in Microsoft Office (Word, Excel, Outlook).
  • Willingness to travel.


The Benefits of Working:
  • Meal vouchers.
  • Mobile phone if requested by the Line Manager.
  • Dedicated Line Manager.
  • Monthly meetings with the line manager.
  • Full performance and development process with end-of-year reviews.
  • Team events and end-of-year party.
  • Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally.
  • Employee satisfaction survey for continuous improvement.


The Application Process:

Apply here online or reach out to Robyn McAllister at Barrington James