Senior Clinical Research Associate

4 weeks ago

West Coast, New Zealand Psi CRO Ag Full time

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,000 driven, dedicated and passionate individuals. We work on the front-line of medical science, changing lives, and bringing new medicines to those who need them.

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

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:

  1. Conduct and report all types of onsite monitoring visits
  2. Be involved in study startup (if applicable)
  3. Perform CRF review, source document verification and query resolution
  4. Be responsible for site communication and management
  5. Supervise study activities, timelines, and schedules on the country level
  6. Be a point of contact for in-house support services and vendors
  7. Be involved in quality control, such as compliance monitoring and reports review
  8. Participate in feasibility research
  9. Support regulatory team in preparing documents for study submissions
Qualifications
  1. College/University degree in Life Sciences or an equivalent combination of education, training & experience
  2. Independent on-site monitoring experience in USA (5 years minimum)
  3. Experience in all types of monitoring visits in Phase II and/or III
  4. Participation in clinical projects as a Lead/Senior Monitor
  5. Experience monitoring complex Oncology (breast cancer) trials required
  6. Full working proficiency in English
  7. Proficiency in MS Office applications
  8. Ability to plan, multitask and work in a dynamic team environment
  9. Communication, collaboration, and problem-solving skills
  10. Ability to travel
  11. Valid driver's license (if applicable)
Additional Information

Advance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company that puts its people first You will get hands-on involvement in every aspect of the study.

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