Clinical Trial Coordinator

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 premier global contract research organization (CRO) dedicated to scientific excellence and equipped with extensive clinical development expertise. We offer a comprehensive suite of clinical development, patient access, and technological solutions across over 20 therapeutic areas, with 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 successful execution of clinical research initiatives. The responsibilities assigned to the CTA will be commensurate with their experience and the value they bring to the project. The CTA is tasked with various study-related functions as dictated by departmental needs, including but 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 related to study activities.
  • Assisting with general administrative tasks as necessary.

Key Responsibilities:
1) Document and monitor study activities utilizing relevant forms and tools, alongside Project Management Systems with appropriate guidance.
2) Aid in the preparation of study and site-specific materials following applicable SOPs.
3) Take minutes and document discussions for sponsor/external or internal teleconferences as required.
4) Assist in establishing and maintaining tracking systems/spreadsheets for study supplies.
5) Keep the Project Directory updated.
6) Support Investigator Meetings by tracking attendees and relevant 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 manage archiving as necessary.
9) Conduct audits and track corrective action plans (CAPA).
10) Set up and manage clinical investigator files and documentation.
11) Coordinate with vendors for study conduct, including printing study materials and facilitating external systems access for team members.
12) Organize and oversee study supply shipments with vendors, confirming shipment details such as tracking numbers and delivery dates.
13) Generate necessary reports, such as CTMS site contact information lists.
14) Collaborate with the In-House CRA and other project team members to reconcile data with CTMS.
15) Execute other administrative duties as assigned by Line Manager, Project Managers, or Clinical Trial Lead.

Qualifications:
• A minimum of one (1) year of administrative experience or equivalent training.
• Strong oral and written communication skills.
• Excellent organizational and time management abilities.
• Proficiency in computer applications, particularly Microsoft Office Suite (Word, Excel, PowerPoint).

At HON Fortrea Hong Kong Limited, we are actively seeking motivated individuals who are adept at problem-solving and possess a creative mindset. Our commitment to transforming the clinical trial landscape ensures the rapid delivery of innovative therapies to patients in need. We foster a collaborative environment that promotes personal growth and enables our team members to make a significant impact on a global scale.

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