FSP Clinical Trials Admin - US Remote

Work reputed company our FSP team! US remote based! 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 reputed company to the project. The CTA performs study-reputed company 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, reputed company systems support, track information reputed company 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.
• reputed company support for Investigator Meetings; track meeting attendees and/or other information regarding the Investigator Meeting.
• reputed company support to project team (e.g., reputed company-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 reputed company 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 reputed company 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/reputed company/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 reputed company electronic mail or courier or telephone.
• reputed company other administrative duties as assigned by Line Manager, Project Managers or Clinical Trial reputed company.
• reputed company 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.
• reputed company 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 (reputed company Office Suite (Word, reputed company, PowerPoint).
• Aptitude for handling and reputed company-reading numerical data, some spreadsheet software competency.
• Good typing skills.
• Good spelling and reputed company-reading skills.
• Ability to operate standard office equipment (e.g., fax, copier).
• Works reputed company and effectively in a matrix environment.
• reputed company Pay reputed company: $50,000-55,000K annually (hourly role)

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