FSPx Clin Trials Admin I (Guangzhou）

Job Overview:

Summary Of Responsibilities:

• Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support.
• Assist in the preparation of study and site-specific materials in accordance with relevant SOPs.
• Complete minute taking and documentation for sponsor/external or internal teleconferences as requested.
• Assist in setting up and maintaining tracking systems/spreadsheets for e.g., study supplies.
• Maintain the Project Directory.
• Provide support for Investigator Meetings; track meeting attendees and/or other information regarding the Investigator Meeting.
• Provide support to project team (e.g., proof-reading and editing correspondence, mailings, shipping of study files, faxing and photocopying documents, assembling study documents, and arranging meetings, etc.).
• Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable.
• Audit and CAPA tracking.
• Set up and maintain clinical investigator files and documentation.
• Liaise with vendors, as needed, for study conduct such as printing study materials and/or external systems access for study team members.
• Coordinate and plan study supply shipments with vendors.
• Maintain and confirm shipment information such as courier tracking numbers and date of shipping and delivery.
• Prepare/assemble/ship supplies to sites pre-SIV: Study File Notebooks, CRFs, other study-specific ancillary supplies (i.e., diary cards, patient visit reminders).
• Generate reports as needed, for example CTMS site contact information list.
• Work with the In-House CRA and other project team members on reconciliation of data with CTMS.
• General communications to sponsors, sites and internal team members via electronic mail or courier or telephone.
• Perform other administrative duties as assigned by Line Manager, Project Managers or Clinical Trial Lead.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• Diploma – Associate degree or equivalent.
• In lieu of the above requirement, candidates with 1-2 or more years of relevant Clinical Research experience in pharmaceutical or CRO industries may be considered.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Speaking English and local language.
• Writing/Reading English and local language.

Experience (Minimum Required):

• Minimum one (I) year administrative experience or equivalent training.
• Good oral and written communication skills.
• Good organizational and time management skills.
• Computer literacy (Microsoft Office Suite (Word, Excel, PowerPoint).
• Aptitude for handling and proof-reading numerical data, some spreadsheet software competency.
• Good typing skills.
• Good spelling and proof-reading skills.
• Ability to operate standard office equipment (e.g., fax, copier).
• Works efficiently and effectively in a matrix environment.

Physical Demands/Work Environment:

• General Office Environment or Home-based.
Travel Requirements:
• 0-20%
• Local.
• Domestic.
• Regional.
• Global.

Learn more about our EEO & Accommodations request here.