Senior CRA / Lead CRA
Sydney, NSW, Australia
1h ago

Company Description

PSI is a leading Contract Research Organization with more than 22 years in the industry / on the market, offering a perfect balance between stability and innovation to both clients and employees.

We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

As a Senior CRA you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications.

You will build and maintain relationships with clinical sites and investigators. You will focus on subjects’ rights, safety and well-being and quality of data compliance.

Office-Based or Home-based

You will :

  • Conduct and report all types of onsite monitoring visits
  • Be involved in study startup (if applicable)
  • Perform CRF review, source document verification and query resolution
  • Be responsible for site communication and management
  • Supervise study activities, timelines, and schedules on the country level
  • Be a point of contact for in-house support services and vendors
  • Be involved in quality control, such as compliance monitoring and reports review
  • Participate in feasibility research
  • Support regulatory team in preparing documents for study submissions
  • Qualifications

  • College / University degree in Life Sciences or an equivalent combination of education, training & experience
  • Independent on-site monitoring experience in Australia
  • Experience in all types of monitoring visits in Phase II and / or III
  • Participation in clinical projects as a Lead / Senior Monitor
  • Experience in Haematology, Oncology, Gastrointestinal
  • Proficiency in MS Office applications
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills
  • Ability to travel
  • Valid driver’s license (if applicable)
  • Additional Information

    Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

    PSI is an inclusive and equal opportunity employer and is committed to attracting and retaining a diverse workforce that reflects the community we serve.

    Applications from Aboriginal and Torres Strait Islanders are encouraged.

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