Clinical Research Associate II

2 days ago


Hobart, Tasmania, Australia Pharmiweb Full time
Job Description

We are seeking a highly skilled Clinical Research Associate II to join our team at Pharmiweb. As a Clinical Research Associate II, you will be responsible for assessing the qualifications of potential clinical study sites, implementing clinical studies at participating sites, managing the conduct of clinical studies at sites, ensuring the quality of site performance, and closing clinical studies.

Key Responsibilities:

  • Evaluate, initiate, monitor, and close out clinical study sites
  • Document all activities in clear, comprehensive, and accurate Monitoring Visit Reports, Contact Reports, and follow-up letters within required timelines
  • Ensure the conduct of clinical studies at sites is in accordance with the protocol/protocol amendments, Good Clinical Practice regulations, International Harmonization Guidelines, applicable company Standard Operating Procedures (SOPs), and all applicable regulatory requirements
  • Properly train/re-train site personnel on the protocol/protocol amendments, systems utilized in the study, and all operational aspects of the trial
  • Serve as primary contact for site personnel, acting as liaison between site personnel and sponsor study team members

Requirements:

  • Bachelor's degree in a Life Science or related field, or RN
  • Minimum of 2+ years of experience in the pharmaceutical/biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock
  • Strong Oncology monitoring experience in phase 1-3 pharmaceutical/biotechnology clinical trials
  • Good understanding and working knowledge of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA, and patient privacy laws, and other relevant, local regulatory requirements

About Us:

At Pharmiweb, we value diversity, inclusion, and belonging. Our rich diversity makes us more innovative, which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organization.



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