Clinical Trial Associate

1 week ago

Subang Jaya, Selangor, Malaysia Agensi Pekerjaan & Perundingcara Bright Prospect Sdn Bhd Full time

To collect and submit regulatory documents to the Ethics Review Board and Competent Authority, communicate and negotiate budgets and contracts with site.


  • Track and ensure site compliance to required training and effectively drive timelines aligned with a company priority.
  • To ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and closeout.
  • Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems.
  • Directly engage with sites to facilitate startup as necessary, and sustain an active partnership with them throughout maintenance and closeout processes.
  • Coordinate translation process for clinical trial documents.
  • Manage/coordinate clinical trial system account request for investigator sites.
  • In charge of accurately entering clinical trial data into various systems, maintaining tracking tools, and ensuring compliance with the company and regulatory standards.
  • To obtain clinical trial authorizations and ethical approvals, execution of the budget and contract, records management, and site training.
  • Supervise the process of purchasing and paying for clinical trial investigator services, including managing vendors, creating and maintaining purchase orders, processing payments for visits and other billable items, and reconciling payments for site closure.
  • Comprehend and adhere to procurement, legal, and financial guidelines, protocols, and directives.

Requirements:

  • Bachelor's degree, preferably in a scientific or healthrelated field.
  • 12 years of
    clinical research/trial capabilities experience or relevant experience preferred.
  • Applicant experience in
    Clinical Trial PurchasetoPay (P2P), is preferred.
  • Applicant with the understanding of the overall clinical development paradigm and the importance of efficient site activation.
  • Applicant with knowledge of
    project management processes and skills.
  • Applicants with experience in
    compliancedriven environment is good.
  • Capacity to understand and adhere to both regulatory mandates and internal policies.
  • Excellent English language skills (comprehension, speaking, reading, and writing).
  • Excellent computer skills.
  • Effective communication and problemsolving skills.
  • Good organization and time management skills.

Salary:
RM4, RM6,000.00 per month

Benefits:

  • Health insurance

Schedule:

  • Monday to Friday

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