Fortrea's FSP team is hiring a Clinical Trial Coordinator- Regulatory - Hybrid in Montreal, Canada. Must be bilingual in French & English. Candidates with strong organizational skills, attention to details, and the ability to manage financial processes effectively will be particularly well suited for the role.
Job Overview:
We are seeking a Clinical Trial Coordinator – Regulatory to serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
Responsibilities:
Serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
Monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.
Assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits).
Perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Fortrea or client data management systems, as assigned by management.
Assist with the coordination of study visits and shipment of drug, ancillary supplies and laboratory kits/samples.
Manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
Liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
Proactively work with sites and project teams to ensure maintenance activities (including Amendments, revised documents, etc.) are completed for assigned sites as applicable in region.
Demonstrate an understanding of the purpose of CTMS, how to use it, and how to navigate within the different sections. To enter weekly details in CTMS or as per study requirement.
Assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable in region.
Facilitate translation and back translation of all necessary documents as appropriate for local country requirements and as needed regionally.
Attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.
Processing site invoices in a timely and accurate manner
Managing routine site payments and reimbursements
Ensuring payment related activities are completed in accordance with study and financial requirements
Collaborating with internal stakeholders to resolve payment inquiries and discrepancies as needed
Required to work within SUVODA and COMET/SAP
Requirements:
At least one year of experience in a related field, (e.g. medical, clinical, pharmaceutical, laboratory research, data analysis, data management or technical writing).
1-2 years of clinical research is required.
Basic understanding of biology and biological processes
Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP.
Good organizational and time management skills
Good communication skills, oral and written
Exhibits general computer literacy
Works efficiently and effectively in a matrix environment
Qualifications (Minimum Required):
University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology).
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
This position is performed through a combination of remote work and in-person at the client's Head Office (2-3 times/week).
Physical Demands/Work Environment:
- General Office Environment.
Learn more about our EEO & Accommodations request here.
Skills Required
- Bilingual in French and English
- 1-2 years of clinical research experience
- At least one year experience in a related field (medical, clinical, pharmaceutical, laboratory research, data analysis, data management or technical writing)
- University/College degree or certification (life science degree preferred)
- Working knowledge of CTMS and ability to enter weekly details
- Experience using SUVODA and COMET/SAP
- Ability to monitor sites per protocol, SOPs, ICH Guidelines and GCP
- Basic understanding of biology and biological processes
- Ability to process site invoices and manage routine site payments and reimbursements
- Good organizational and time management skills
- Good oral and written communication skills
- General computer literacy
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
