Clinical Trial Coordinator – Regulatory & Finance - Hybrid, Montreal

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
- R equired 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

- Exhibit s   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 .