Clinical Research Associate

4 days ago


Petaling Jaya, Selangor, Malaysia Parexel International Full time

About the Role:

We are seeking a highly skilled Clinical Research Associate to join our team at Parexel International. As a Clinical Research Associate, you will be responsible for ensuring the overall integrity of study implementation and adherence to study protocol at clinical sites.

  • You will act as Parexel's direct contact with assigned sites, building relationships with investigators and site staff.
  • Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
  • Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.

Your Key Responsibilities:

Manage start-up activities, including feasibility and/or site pre-qualification and qualification visits.

  • Conduct remote Qualification Visits (QVs) and generate visit/contact reports.
  • Develop strategy to configure, distribute, collect, review and approve high quality country specific and/or site specific documents or essential regulatory documents (SRP).
  • Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.

Maintenance Activities:

Act as Parexel's direct contact with assigned sites during the maintenance phase, assessing and ensuring overall integrity of study implementation and adherence to study protocol.

  • Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
  • Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
  • Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.

Skills and Qualifications:

  • Problem-solving skills and ability to work independently.
  • Sound presentation skills and client-focused approach to work.
  • Able to interact professionally within a client organization.
  • Flexible attitude with respect to work assignments and new learning.
  • Ability to manage multiple tasks and achieve project timelines.


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