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Jobs in Malaysia   »   Jobs in Petaling Jaya SGR   »   Education / Training jobs   »   Clinical Research Associate II

Clinical Research Associate II

Petaling Jaya SGR
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Why Work at PAREXEL

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?
That’s PAREXEL. We’re a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.
How can we help you on your journey? Find your path, and learn more on LinkedIn , YouTube , Facebook , Twitter , and Glassdoor .


Job Description
PAREXEL provides monitors with world class technology, training resources, and limited protocol load. You will also be rewarded for your hard work through our CRA bonus incentive program and career advancement opportunities.
Your Key Accountabilities:
  • Perform all clinical monitoring/site management activities for assigned projects in accordance with PAREXEL's standard operating procedures
  • Act as PAREXEL's direct contact with assigned clinical sites, and use judgment to assess and ensure overall integrity of study implementation, as well as adherence to study protocol
  • Conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites
  • Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Function as a mentor and role model for other CRA team members
  • Manage clinical monitoring activities, including:
    • Arranging on-site visits and logistics
    • Establishment of a site recruitment plan in collaboration with site staff during QV
    • Monitoring completeness and quality of Regulatory Documentation
    • Performing site documentation verification
    • Data collection and drug accountability in accordance with ICH GCP guideline
    • Monitoring patient safety on-site and addressing any violations in a timely manner

Qualifications
Your Skillset:
  • Minimum 2 years of monitoring experience in clinical research
  • Educated to degree level (biological science, pharmacy or other health related discipline)
  • Strong working knowledge of EDC systems and IVRS
  • Experience of CTMS preferred
  • Competent in written and oral English and local language
Our Offer:
We offer you a fascinating and diversified insight into PAREXEL and an exciting journey through the world of clinical research.
You can expect to work with a successful, highly-qualified and dynamic team as you develop your individual scientific profile. You can also look forward to a flexible working environment and a pleasant atmosphere.
If you are ready to join PAREXEL’s Journey, please apply!
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