clinical research associates jobs

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)