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    • Good knowledge of medical terminology and clinical/medical practices.
    • Develop, compile and/or review all study-related regulatory and administrative documents…
    • View all CMIC ASIA PACIFIC (MALAYSIA) SDN. BHD jobs - Kuala Lumpur jobs - Clinical Assistant jobs in Kuala Lumpur
    • Salary Search: Clinical Trial Assistant salaries in Kuala Lumpur
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Job Post Details

Clinical Trial Assistant - job post

CMIC ASIA PACIFIC (MALAYSIA) SDN. BHD
Kuala Lumpur
RM 3,000 - RM 7,000 a month - Contract

Job details

Pay

  • RM 3,000 - RM 7,000 a month

Job type

  • Contract

Location

Kuala Lumpur

Full job description

Job Description & Requirements

  • Develop, compile and/or review all study-related regulatory and administrative documents from investigational sites, monitoring visit reports, work progression reports and other study-required documents
  • Develop, compile and/or submit dossiers include initial/amendment/interim report/safety reporting to regulatory and/or ethics committee for review and follow up until approval, as required
  • Support in safety reporting to regulatory and/or ethics committee and/or Investigator as required
  • Support in planning, coordinating, organizing and attending all study-related meetings and activities for sites as required
  • Support/assist in feasibility studies, site and investigator identification as required
  • Manage/support project(s) in the capacity of Clinical Trial Assistant ( CTA) and/or other designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the Company
  • Support/Assist in Site and CRO audit or inspection as required
  • Assist to set up, review and maintain project files to ensure compliance to ICH E6 GCP, applicable local regulatory and project requirements
  • Maintenance and support study document filing/upload to e-TMF system and internal document QC related process
  • Support the organization of the office monthly operations meeting
  • Support internal/external study finance process
  • Support business development activities (e.g. search new project related information)
  • [AD] Handles and/or coordinates office administrative work, including purchasing, policy dissemination, office operations/maintenance, Legal and IT support. Ensure all transactions are reasonable, appropriate, and necessary
  • [AD] Provide support to management on all finance and administration matters.
  • Maintain the environmental control of the document archiving room. When DRM is absent, ensure that storage/ filing facility is secured with limited access and compliance.

Work Experiences, Skills and Personal Qualities

  • Minimum diploma or bachelor degree (major in nursing, pharmacy or other science-related background) from a recognized institution, and/or equivalent combination of training and experience in clinical research
  • Certificate in basic GCP course
  • Good knowledge of medical terminology and clinical/medical practices
  • Job Type: Contract
  • Candidates who are seeking for CRA and CPS role within the CRO industry are also welcomed to apply.
  • Due to limited applicants from the job post, you may send your resume to pearlyn-tan@cmicgroup.com

Benefits (Pro-rated):

  • Cell phone reimbursement
  • Dental insurance
  • Health insurance
  • Professional development
  • Work from home

Schedule:

  • Monday to Friday

Supplemental Pay:

  • Contract Completion Bonus

Pay: RM3,000.00 - RM7,000.00 per month

Benefits:

  • Flexible schedule
  • Work from home

Work Location: Hybrid remote in Kuala Lumpur (Kuala Lumpur)

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