Clinical Trial Coordinator-regulatory

2 weeks ago

Montréal, Canada Labcorp Full time

**Clinical Trial Coordinator - Regulatory**

**Hybrid-Canada**

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.

**Did you know?**

**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.

Our Energizing Purpose, Exceptional People and Extraordinary Potential combined with collaborative and proactive teams offer a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research. Our reach is global - extending to 60+ countries making us one of the largest FSP CROs. So, no matter where you are located on the globe, we have an FSP opportunity for you.

We are seeking a** Clinical Trial Coordinator** - **Regulatory **to act as primary contact with investigative sites during study maintenance and -when assigned-, site start-up activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the timelines agreed with project management and Site Readiness team.

**Responsibilities**:

- Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
- Collect and track all the necessary documents required and perform a quality review, formatting and compilation of the final documents for effective and compliant site activation and maintenance
- Update study documents when there are changes in study personnel/study amendments
- Ensure high quality documents are filed and systems are updated on an ongoing and timely basis
- Update status reports, applicable logs and tracking systems as applicable for the projects with input provided by senior staff
- Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable
- Assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable
- Attend and present (as applicable) at meetings (e.g. sponsor, kick-off, face-to-face, study team)

This position is performed through a combination of remote work and in-person at the client's Head Office.

**Requirements**:

- B.A./B.S. (Life Science preferred) or equivalent healthcare experience
- Minimum 1-2 years of clinical research or relevant healthcare experience
- Fluent in French and English (verbal and written) and excellent communication skills
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Effective time management, organizational and interpersonal skills
- Effective communication with external customers (e.g. sites and investigators)
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
- Works efficiently and effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to customer focus, both internally and externally.
- Able to work independently and as a team

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp 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.

For more information about how we collect and store your personal data, please see our Privacy Statement.

  • Clinical Trial Coordinator

    4 weeks ago

    Montréal, Canada Fortrea Full time

    Clinical Trial Coordinator - Regulatory Hybrid (50% office-based / 50% remote) - Montreal, QC 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...

  • Clinical Trial Administrator

    4 weeks ago

    Montréal, Canada Fortrea Full time

    Clinical Trial Administrator, FSP Hybrid (50% client office-based / 50% remote) - Montreal, Quebec Must Commute to Client Office Two Days/Week 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 Trial Administrator

    4 weeks ago

    Montréal, Canada Fortrea - Organic Full time

    Clinical Trial Administrator 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...

  • Clinical Trials Administrator I

    6 days ago

    Montréal, Canada Labcorp Full time

    **Clinical Trial Administrator - FSP** **Hybrid Office/Home-Based - Montreal, Quebec** **Must be bilingual (English/French)** As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug...

  • Unit Manager

    4 days ago

    Montréal, Canada Centre universitaire de santé McGill Full time

    **Organization description** Le Centre universitaire de santé McGill (CUSM) est un centre hospitalier universitaire intégré, reconnu à l’échelle internationale pour l’excellence de ses programmes cliniques, de sa recherche et de son enseignement. Le CUSM a pour objectif d’assurer aux patients des soins fondés sur les connaissances les plus...

  • Fsp - Clinical Project Manager

    2 hours ago

    Montréal, Canada Allphase Clinical Research Inc. Full time

    **Job Title**: FSP - Clinical Project Manager **Date**: May 17, 2024 **Location**: Montreal, QC **Remote**: Yes **Business Unit**: Health **Division**: Pharma - CRO - Do you want the opportunity to be embedded within big pharma? - Do you want to drive the strategy, planning and implementation of local research to address healthcare system gaps and ensure the...

  • Clinical Research Coordinator

    3 days ago

    Montréal, Canada Centre universitaire de santé McGill Full time

    **Organization description** Le Centre universitaire de santé McGill (CUSM) est un centre hospitalier universitaire intégré, reconnu à l’échelle internationale pour l’excellence de ses programmes cliniques, de sa recherche et de son enseignement. Le CUSM a pour objectif d’assurer aux patients des soins fondés sur les connaissances les plus...

  • Clinical Research Manager

    4 weeks ago

    Montréal, Canada Fortrea - Organic Full time

    Clinical Research Manager Remote - Montreal, Quebec 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...

  • Clinical Research Manager

    5 days ago

    Montréal, Canada Fortrea Full time

    Clinical Research Manager Remote - Montreal, Quebec 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...

  • Clinical Team Lead

    4 weeks ago

    Montréal, Canada Labcorp Full time

    **Clinical Team Lead** **Remote - Canada** **CRA and Lead Monitor Experience in Pharma and/or CRO Required** As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the...

  • Clinical Trial Liaison

    4 weeks ago

    Montréal, Canada Syneos Health Clinical Full time

    **Overview** **Vous êtes un expert extraverti, à la fois chercheur et communicatif, scientifique et social.** S’il y a une chose que votre préparation à l’obtention de votre diplôme d’études supérieures vous a apprise, c’est comment faire évoluer votre expertise rapidement et rester à l’avant-garde de votre domaine. Forger de nouvelles...

  • Sso Clinical Project Manager

    4 weeks ago

    Montréal, Canada Novartis Full time

    100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have! #GCO The SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting, (from...

  • Institutional Clinical Research Educator

    7 days ago

    Montréal, Canada Centre universitaire de santé McGill Full time

    **RESEARCH INSTITUTE OF THE MUHC** The Research Institute of the McGill University Health Centre (RI-MUHC) is a world-renowned biomedical and hospital research centre. Located in Montreal, Quebec, the Institute is the research arm of the McGill University Health Centre (MUHC) affiliated with the Faculty of Medicine at McGill University. The RI-MUHC is...

  • Clinical Data Coordinator

    7 days ago

    Montréal, Canada Innovaderm Research Full time

    The Clinical Data Coordinator will participate in various clinical data management activities required to ensure that data captured in clinical trials undertaken, or managed by Innovaderm, are collected, managed and reported clearly, accurately and securely. In addition, this position is required to conduct all these activities in conformance with applicable...

  • Medical Research Manager

    1 week ago

    Montréal, QC, Canada Parexel Full time

    PXL is seeking a Clinical Research Manager (CRM) in Canada for one of our large FSP clients! This is a remote position with some travel. Oncology experience is preferred! The Clinical Research Manager (CRM) is responsible for the following: Primarily accountable for end-to-end performance and project management for assigned protocols in a country in...

  • Senior Clinical Research Associate

    2 days ago

    Montréal, Canada Barrington James Full time

    Canadian based CRA needed for two sites one in Toronto the other in Montreal.MUST HAVE RECENT ONCOLOGY EXPERIENCE!!! T4 contract only. 0.25 FTE consultant needed for long term project. SummaryThe Clinical Research Associate plays a vital role in the Clinical Operations team. Through responsibilities like monitoring studies, reviewing data, and engaging with...

  • Clinical Research Coordinator

    6 days ago

    Montréal, Canada Centre universitaire de santé McGill Full time

    Organization description Le Centre universitaire de santé McGill (CUSM) est un centre hospitalier universitaire intégré, reconnu à l’échelle internationale pour l’excellence de ses programmes cliniques, de sa recherche et de son enseignement. Le CUSM a pour objectif d’assurer aux patients des soins fondés sur les connaissances les plus avancées...

  • Quality Assurance

    3 weeks ago

    Montréal, Canada NeuroRx Research Full time

    **The role**: The Quality Assurance / Quality Control Coordinator is part of NeuroRx’ QA Unit and is responsible for internal Quality Assurance (QA) monitoring activities as well as for Quality Control (QC) of MRI related data in our database. Duties of the Quality Assurance / Quality Control Coordinator include: - QC of quantitative measurement results...

  • Quality Assurance

    3 days ago

    Montréal, Canada NeuroRx Research Full time

    **The role**: The Quality Assurance / Quality Control Coordinator is part of NeuroRx’ QA Unit and is responsible for internal Quality Assurance (QA) monitoring activities as well as for Quality Control (QC) of MRI related data in our database. Duties of the Quality Assurance / Quality Control Coordinator include: - QC of quantitative measurement results...

  • Trial Master File Specialist | Spécialiste, dossier principal d’essai

    2 weeks ago

    Montréal, QC, Canada 35Pharma Full time

    Trial Master File Specialist Reporting to the Senior Director, Clinical Operations, the Trial Master File Specialist is responsible for all aspects of the trial master file (TMF) management operations to ensure study documents are collected, reviewed, processed, filed, and archived in compliance with International Council for Harmonisation (ICH):...