Clinical Research Project Specialist - #1165021

Job Purpose

Responsible for the end-to-end coordination and management of clinical studies, ensuring compliance, quality, and timely execution from study start-up to close-out within a CRU/Phase I unit environment.

Key Responsibilities

• Manage clinical study activities from planning, initiation, conduct, to close-out.

• Coordinate with sponsors, investigators, ethics boards (IRB/ERB), monitors, and internal CRU teams.

• Support protocol development and review of essential study documents (protocols, ICFs, CRFs, worksheets).

• Oversee study risk assessment, subject safety reporting, and regulatory submissions (e.g. IRB approvals, SAEs, deviations).

• Track study timelines, budgets, and provide regular progress updates; escalate issues when necessary.

• Coordinate site initiation, monitoring visits, training, and study meetings.

• Ensure proper maintenance of Trial Master Files and study documentation.

• Manage vendors, study logistics, and supply coordination (e.g. investigational products, lab kits).

• Support audits, inspections, SOP updates, and continuous process improvements.

Requirements

• Diploma/Degree in Nursing, Life Sciences, or related health/science field

• Minimum 5 years of clinical research experience

• Strong knowledge of GCP and clinical trial processes

• Good project management, communication, leadership, and stakeholder management skills

• Familiar with CRU or Phase I clinical research operations (preferred)

• Willing to travel when required

Interested applicants, kindly furnish us with your detailed resume in MS Words format and click "Apply Now" button

We regret to inform only shortlisted candidates will be notified. Applicants who do not possess necessary experience or qualification will still be considered on individual merits and may be contacted for other opportunities

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