Clinical Trial Administrator Jobs

Montreal, QC

Hybrid 50% client office / 50% home-based

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.

We are seeking a Clinical Trial Administrator (CTA), an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The CTA is an administrative support role for clinical trials. The CTA performs study-related tasks as required by the department.

Additional responsibilities include:

• 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
• Prepare/assemble/ship supplies to sites pre-SIV: Study File Notebooks, CRFs, other study-specific ancillary supplies (i.e. diary cards, patient visit reminders).
• Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support
• Assist in setting up and maintaining tracking systems/spreadsheet for e.g. study supplies
• Perform other administrative duties as assigned by Line Manager, Project Managers or Clinical Trial Lead.
• General communications to sponsors, sites and internal team members via electronic mail or courier or telephone
• Audit and CAPA tracking
• Generate reports as needed, for example CTMS site contact information list
• Maintain the Project Directory
• Coordinate and plan study supply shipments with vendors
• 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.
• Set up and maintain clinical investigator files and documentation
• Communicate with project team members regarding study updates
• Assist in the preparation of study and site-specific materials in accordance with relevant SOPs
• Activities will be conducted in compliance with Company or Sponsor SOPs and regulatory standards and guidelines applicable.
• Work with other clinical operations project team members on reconciliation of data with CTMS.
• Maintain and confirm shipment information such as courier tracking numbers and date of shipping and delivery
• Liaise with vendors, as needed, for study conduct such as printing study materials and/or external systems access for study team members.

Requirements:

• Minimum 1 year experience in clinical research or related work experience
• Proficient English and French skills, conversational and written
• Ability to manage multiple priorities and able to accomplish tasks within a timeframe including setting milestones to meet deadlines and to achieve goals
• Identify and communicate appropriately with key stakeholders both by phone and email communication
• Able to work independently as well as part of a team
• Two year degree required
• 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
• Technologically proficient in MS office applications, Teams, SharePoint (file management and database)
• Willing and able to support clinical operations team with report running, communications, and information management as needed

Preferred:

• Four year undergraduate degree preferred
• Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems
• Additional complex software application experience related to clinical trial research (i.e. EDC or patient diaries, IVRS, etc)

Great Benefits at Labcorp:

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including:

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

Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit www.fortrea.com.

Fortrea 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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