Clinical Research Associates

2 weeks ago

Kuala Lumpur, Kuala Lumpur, Malaysia RF Staffing and Outsourcing Solutions Sdn. Bhd. Full time

Responsibilities:

  • Initiate investigator site activities, including collection and submission of regulatory documents to Ethics Review Board and Competent Authority, communicate and negotiate budgets and contracts with site, track and ensure site compliance to required effectively drive timelines aligned with company priority.
  • Communicate with sites, Lilly functions, clinical research organization to enable startup and maintain an active collaboration with sites during maintenance and closeout.
  • Ensure countryspecific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems.
  • Compose initial Informed Consent Form or amendments based on country ICF template as well as response to queries by Ethic Committees.
  • Coordinate the management and delivery of clinical trial material to ensure support of site initiation.
  • Populate internal clinical trial systems (e.g., Vault Clinical, Shared Investigator Platform, IMPACT) to allow tracking, performance metrics reporting and to meet regulatory compliance requirements.
  • Ensure complete, accurate and readily available Trial Master File.

Requirements:

  • At least Bachelor's degree preferably in a scientific or health related field, postgraduate degree is also welcomed.
-
1-4 years clinical research experience or relevant experience preferred
:

  • Understanding of the overall clinical development paradigm and the importance of efficient site activation.
  • Applied knowledge of project management processes and skills.
  • Appreciation of / experience in compliancedriven environment.
  • Effective communication, negotiation, and problemsolving skills.
  • Selfmanagement, able to multitask and good organizational skills.

-
Language capabilities
 English (read, write, conversation
Salary:

RM3, RM8,200.00 per month

Ability to commute/relocate:

  • Kuala Lumpur: Reliably commute or planning to relocate before starting work (required)

Application Question(s):

  • Do you have experience in clinical trial?
  • Do you have 14 years clinical research experience or relevant experience preferred?
  • Do you have Bachelor's degree preferably in a scientific or health related field, postgraduate?
degree is also welcomed

Language:

  • English (required)

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