Global Trial Coordinator

3 days ago


Kuala Lumpur, Kuala Lumpur, Malaysia Psi CRO Ag Full time

We are a mature and experienced Contract Research Organization (CRO) with a strong presence in the global clinical research industry. Our company has grown organically from a handful of countries to a global presence, while maintaining our independence and freedom to operate.

Job Responsibilities

We are seeking a skilled Senior Clinical Research Associate to join our team in Malaysia. As a Senior CRA at PSI CRO Ag, you will work closely with project stakeholders to ensure the successful conduct of clinical trials in various therapeutic indications.

Your key responsibilities will include:

  1. Managing study activities, timelines, milestones, and schedules on the country level.
  2. Conducting and reporting all types of onsite monitoring visits.
  3. Participating in study set-up, including site contract and budget negotiations.
  4. Maintaining site communication and management.
  5. Ensuring consistency of all study processes and identifying country differences.
  6. Oversight of study-specific and corporate tracking systems.
  7. Contributing to the development and update of project planning documents, essential documents, and project instructions.
  8. Serving as a point of contact for in-house support services, contractors, global cross-functional teams, and vendors.
  9. Executing and overseeing clinical trial country submissions and approvals for assigned protocols.
  10. Development of local language materials, including informed consents and translations.
Requirements

To be considered for this position, you must have:

  • A Bachelor's degree in Life Sciences, Pharmacy, or Registered Nursing; or an equivalent combination of education, training, and experience.
  • Minimum 4-5 years of independent on-site monitoring experience or equivalent expertise.
  • Extensive experience conducting all types of monitoring visits in Phase II and/or III clinical trials.
  • Proficiency in feasibility assessment and study set-up processes is highly desirable.
  • Specialized experience in Oncology or Hematology therapeutic indications is a significant advantage.


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