Clinical Trial Administrator

7 days ago

Hong Kong, Central and Western District, Hong Kong SAR China HON Fortrea Hong Kong Limited Full time

Company Overview:
HON Fortrea Hong Kong Limited is a prominent global contract research organization (CRO) dedicated to scientific excellence and extensive clinical development expertise. We offer a diverse array of clinical development, patient access, and technological solutions across over 20 therapeutic areas, supported by a workforce of more than 19,000 professionals operating in over 90 countries. Our mission is to innovate drug and device development for our partners and patients worldwide.

Position Summary:
The Clinical Trial Administrator (CTA) plays a pivotal role within a Clinical Project Team, ensuring the effective execution of clinical research initiatives. The responsibilities assigned to the CTA will correspond to their experience and the value they bring to the project. The CTA will undertake various study-related tasks as mandated by the department, which include, but are not limited to:

  • Facilitating communication among project team members regarding study progress.
  • Maintaining documentation in accordance with protocols, standard operating procedures (SOPs), and regulatory requirements to guarantee the timely generation of high-quality clinical data.
  • Providing systems support and tracking information pertinent to study activities.
  • Assisting with general administrative functions as necessary.

Key Responsibilities:
1) Document and monitor study activities utilizing relevant forms and tools, alongside appropriate Project Management Systems with guidance.
2) Aid in the creation of study and site-specific materials per relevant SOPs.
3) Record minutes and documentation for sponsor/external or internal teleconferences as needed.
4) Assist in establishing and maintaining tracking systems/spreadsheets for study supplies.
5) Manage the Project Directory.
6) Support Investigator Meetings by tracking attendees and other pertinent information.
7) Provide assistance to the project team, including proofreading and editing correspondence, managing mailings, shipping study files, and organizing meetings.
8) Maintain Trial Master File documentation within the designated TMF platform, participate in TMF quality control as assigned, and track/archive as necessary.
9) Conduct audits and track corrective actions.
10) Set up and maintain clinical investigator files and documentation.
11) Liaise with vendors for study conduct, including printing study materials and providing external systems access for team members.
12) Coordinate and plan study supply shipments with vendors.
13) Maintain and verify shipment details, such as courier tracking numbers and shipping dates.
14) Prepare, assemble, and ship supplies to sites prior to site initiation visits, including study file notebooks and other study-specific materials.
15) Generate necessary reports, such as CTMS site contact information lists.
16) Collaborate with the In-House CRA and other project team members to reconcile data with CTMS.
17) Manage general communications with sponsors, sites, and internal team members through electronic mail or other means.
18) Perform additional administrative duties as assigned by the Line Manager, Project Managers, or Clinical Trial Lead.

Qualifications:
• A minimum of one year of administrative experience or equivalent training.
• Strong oral and written communication skills.
• Excellent organizational and time management abilities.
• Proficiency in computer applications, including Microsoft Office Suite (Word, Excel, PowerPoint).

At HON Fortrea Hong Kong Limited, we are seeking motivated individuals who are problem-solvers and innovative thinkers. Our commitment is to enhance the clinical trial process, ensuring the rapid delivery of transformative ideas and therapies to patients in need. We foster a collaborative environment that promotes personal growth and enables you to make a significant impact on a global scale.

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