Clinical Research Associate II

2 days ago


Gold Coast, Queensland, Australia Pharmiweb Full time

The Clinical Research Associate II will perform site activities for Phase I-IV studies as the primary point of contact for the site during a study. This role involves driving and executing monitoring plans, ensuring site GCP compliance, writing trip reports, resolving issues, and facilitating open issue resolution. Additionally, the CRA will conduct site qualification visits, site initiation visits and site training, routine monitoring visits, and site close-out visits, all while performing investigator site management activities in adherence to applicable regulatory guidelines and standard operating procedures.

About the Role
  • Independent, proactive work to set up and monitor studies, complete reports, and maintain documentation
  • Submitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissions
  • Balancing sponsor generated queries
  • Taking responsibility for study cost efficiency
  • Preparation and review of study documentation and feasibility studies for new proposals
  • Potential to assist in training and mentoring fellow CRAs

Requirements

  • At least 18 months of experience as an independent CRA, including conducting monitoring visits for clinical trials, from either a pharmaceutical company or a CRO environment
  • A working knowledge of ICH-GCP guidelines and local and international regulatory requirements
  • Educated to degree level in a life science discipline or be a licensed healthcare professional
  • Fluency in German and English
  • Scientific degree (BSc, MSc or PhD), have equivalent experience, or be a licensed healthcare professional
  • Excellent verbal and written communication skills in German and English
  • Ability to manage sites independently

At Pharmiweb, we offer a comprehensive and competitive total reward package that comprises an excellent level of base pay, variable pay, and recognition programs. Our best-in-class employee benefits, supportive policies, and wellbeing initiatives are tailored to support you and your family at all stages of your career. We are committed to developing our employees in a continuous learning culture, where every experience adds to your professional development.



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