Clinical Trial Administrator

5 months ago

Montréal, Canada Fortrea Full time

Clinical Trial Administrator

Montreal, QC

Hybrid 50% client office / 50% home-based

Bilingual in English and French required

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Why settle for one thing when you can have everything? Fortrea gives you the best two for one opportunity for career growth. Who doesn’t want twice the perks - working at one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus.

Additional responsibilities include:
- 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.- 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- Assist in setting up and maintaining tracking systems/spreadsheet for e.g. study supplies- Maintain the Project Directory- 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 other clinical operations 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.

**Requirements**:
- Associate degree or equivalent; 1 or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered in lieu of degree requirement- Minimum 1 year experience in clinical research or related work experience-
- Able to work independently as well as part of a team- Ability to manage multiple priorities and able to accomplish tasks within a timeframe including setting milestones to meet deadlines and to achieve goals-
- Willing and able to support clinical operations team with report running, communications, and information management as needed- Basic understanding of ICH GCP Guidelines and local regulations- Basic knowledge of the drug development process as it relates to the execution of clinical trials with a focus on document flow- Proficient English and French skills, conversational and written

Preferred:
- Four year undergraduate degree preferred- Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File SystemsFortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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