Clinical Trial Administrator | Oslo Area

Fortrea Development India Private Limited; Oslo fylke; Sur place; NOK 360 000 - 560 000; Plein temps

Résumé du poste

Fortrea Development India Private Limited in Norway seeks a Clinical Trial Administrator to support Clinical Project Teams. You will document study activities, prepare materials, and maintain TMF documentation to ensure quality data.

The role requires fluency in English and the local language, strong organizational skills, and experience with MS Office. This is an entry-to-mid level position with opportunities as future opportunities arise.

Qualifications

• Diploma – Associate degree or equivalent.
• 1-2 years of relevant clinical research/administrative experience may be considered.
• Fluent in English and local language (speaking and writing).
• Computer literacy with Microsoft Office Suite (Word, Excel, PowerPoint).

Responsabilités

• Document and track study activities using forms and project management systems.
• Prepare study and site materials in line with SOPs.
• Take minutes for sponsor/internal meetings and distribute notes.
• Maintain TMF documentation and assist with TMF QC.
• Coordinate study supply shipments and maintain tracking.
• Liaise with vendors for study materials and access needs.
• Generate site contact lists and basic reports as required.

Connaissances

Administration

Communication

Organization

Attention to detail

Formation

Diploma/ Associate degree

Outils

Microsoft Office

Description du poste

Are you looking to kickstart your career in clinical research and gain experience in a global CRO environment? Are you a proactive, detail-oriented individual who enjoys working in a dynamic international setting? Do you already have some understanding of clinical trials and want to develop your career within a world-leading clinical research organization?

Join our talent pool and be among the first to be considered for exciting Clinical Trial Administrator opportunities as they become available.

This role is for upcoming future opportunities that may arise at Fortrea in Norway.

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 (fluent).
• Writing/Reading English and local language (fluent).

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.

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