Clinical Trials Associate, FSP

Benefits

Job Description

Qualifications

• •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)
• •FSP experience
• •CRO oversight
• •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

Responsibilities

• •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
• •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