Clinical Research Associate

Other, Federal Territory of Kuala Lumpur, Malaysia
MYR 6,500
Health
Manufacturing

Executive recruitment company Monroe Consulting Group's Health Division Malaysia is recruiting on behalf of a global clinical research organization in Malaysia. Our client is a global clinical research organization conducting best class studies in biopharmaceutical and medical device studies.

As business growth and expansion continues, our respected client is seeking a professional with minimum of three to five years of experience in conducting research studies for the contract opportunity as Clinical Research Associate. This opportunity is based in Kuala Lumpur, Malaysia

Job responsibilities:

  • Provide daily research support for the assigned research projects and related activities 
  • Executes clinical studies and/or programs in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures through successful collaboration with key opinion leaders across therapies and approved CRO partners
  • Provides trial operation, site management, ethics and regulatory authority level coordination of assigned clinical studies and at the site level to verify that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements
  • Ensure clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence
  • Assist in developing research study procedure and policies 
  • Ensure any identified non-compliance issues are addressed, clearly communicated, documented, and escalated as required through monitoring visits, analysing study metrics, and general study data overview. Participate actively in study-specific meetings, teleconference, and trainings. Collaborates with cross-functional team members and study sites throughout all study phases
  • Manage study contracts, request / collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator / site documentation, review, and approval of subset of documents in applicable database
  • Demonstrate a high level of professional behaviour at all time

Job requirements:

  • BS Degree in Science/ Health related fields 
  • Prior working experience in clinical trial related field related to study planning executing, monitoring and experience in facilitating study would be added leverage 
  • Prior experience in in with clinical trials in phase I-IV would be added leverage 
  • Strong verbal, written communication, and presentation skills 
  • Strong interpersonal skills and able to perform independently
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