FSP Clinical Trials Admin - US Remote

Fortrea; United States; Remote; USD 50,000 - 55,000; Full time

Job summary

A global leader in clinical trials, Fortrea seeks a Clinical Trials Administrator to join their remote team. This entry-level role focuses on supporting clinical research projects by documenting activities, managing communications, and maintaining essential files. Ideal candidates have an Associate degree or equivalent experience, with strong organizational and communication skills.

Qualifications

• 1-2 years of relevant Clinical Research experience may be considered in lieu of degree.
• Experience in pharmaceutical or CRO industries is preferred.

Responsibilities

• Document and track study activities using relevant forms and tools.
• Assist in the preparation of study and site-specific materials.
• Maintain the Project Directory and support Investigator Meetings.

Skills

Good oral and written communication skills

Good organizational and time management skills

Computer literacy

Aptitude for handling and proof-reading numerical data

Good typing skills

Good spelling and proof-reading skills

Education

Diploma – Associate degree or equivalent

Tools

Microsoft Office Suite

Job description

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Job Overview

The Clinical Trial Administrator (CTA) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to the CTA shall reflect their experience, and level of contribution which they can make to the project. The CTA performs study-related tasks as required by the department, including (but not limited to): communicate with project team members regarding study updates, maintain documentation as required by protocols, SOPs and regulatory standards, to ensure timely production of high quality clinical data, provide systems support, track information related to the status of study activities and assist with general administrative functions as required. Activities will be conducted in compliance with Company or Sponsor SOPs and regulatory standards and guidelines applicable.

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.
• Target Pay Range: $50,000-55,000K annually (hourly role)
  
  

Learn more about our EEO & Accommodations request here.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

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