Clinical Trials Associate, FSP jobs in United States
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Fortrea · 21 hours ago

Clinical Trials Associate, FSP

Fortrea is looking to hire Clinical Trial Administrators for their FSP Team in the US, requiring prior clinical research experience. The Clinical Trial Administrator (CTA) will be responsible for executing clinical research projects, maintaining documentation, and providing support to project team members to ensure high-quality clinical data production.

Clinical TrialsHealth Care

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

Qualification

Clinical research experienceGCPICH guidelinesMicrosoft Office SuiteOrganizational skillsTyping skillsProof-reading skillsMatrix environment efficiencyStandard office equipment operationCommunication skillsTime management skills

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
1+ year of experience in a clinical research setting (Clinical Trial Assistant, Study Coordinator, or similar)
General knowledge of applicable clinical research principles and requirements, including GCP and ICH guidelines
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

Benefits

Medical
Dental
Vision
Life
STD/LTD
401(K)
ESPP
Paid time off (PTO) or Flexible time off (FTO)
Company bonus where applicable

Company

Fortrea

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Fortrea is a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions.

Funding

Current Stage
Late Stage

Leadership Team

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Anshul Thakral
Chief Executive Officer
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Agnieszka Gallagher
General Counsel, Chief Compliance Officer and Corporate Secretary
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Company data provided by crunchbase