Senior Clinical Research Associate

16 hours ago

Work from Home, Philippines Zillan Clinical Research Full time ₱708,000 - ₱912,000 per year

Job Overview

We are seeking a highly organized and experienced Clinical Research Associate (CRA) to support U.S. clinical trial sites with a focus on regulatory documentation, quality control, data entry, trial compliance, and site operational support. This individual will ensure that all study activities are conducted in accordance with ICH-GCP, FDA regulations, protocol requirements, and company SOPs.

Key Responsibilities

  • Manage and maintain regulatory documents, TMF files, and site binders.
  • Support IRB submissions, amendments, renewals, and regulatory updates.
  • Perform ongoing quality checks of study documents, data, and compliance logs.
  • Conduct remote monitoring, identify deviations, and assist with CAPA resolutions.
  • Support audit preparation and follow-up activities.
  • Provide daily operational support to U.S. clinical sites and respond to protocol-related questions.
  • Coordinate site start-up activities, training, and readiness tasks.
  • Track enrollment, queries, study progress, and site performance to ensure GCP and FDA compliance.
  • Train new CRCs

Required Qualifications

  • Bachelor's degree in life sciences, nursing, public health, or related field.
  • 4+ years of experience in clinical research, regulatory affairs, monitoring, or quality.
  • Strong knowledge of ICH-GCP guidelines, FDA clinical trial regulations, and standard site documentation.
  • Experience with TMF systems, CTMS, EDC, and regulatory systems (e.g., IRB portals).
  • Excellent communication, organization, and documentation skills.
  • Ability to work independently and support multiple sites simultaneously.
  • Ability to work in USA CST and PST time zones

Job Type: Full-time

Pay: Php59, Php76,000.00 per month

Experience:

  • Clinical research: 4 years (Preferred)

Work Location: Remote

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