Clinical Trial Coordinator

7 months ago

Montréal, Canada ICON Full time

As a Clinical Trial Coordinator you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

**What you will be doin**g**:
**Clinical Trial Coordinator (CTC)**

**Trial and site administration**:

- Track (e.g. essential documents) and report (e.g. Safety Reports)
- Ensure collation and distribution of study tools and documents
- Update clinical trial databases (CTMS) and trackers
- Clinical supply & non-clinical supply management, in collaboration with other country roles
- Manage Labeling requirements and coordinate/sign translation change request

**Document management**:

- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents, e.g. eTMF
- Assist with eTMF reconciliation
- Execute eTMF Quality Control Plan
- Update manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
- Obtain translations of documents

**Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to**:

- In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
- Obtain, track and update study insurance certificates
- Support preparation of submission package for IRB/ERC and support regulatory
- agencies submissions.
- Publish study results for GCTO and RA where required per local legislation
- Budgeting, Agreement and Payments:
Collaborate with finance/budgeting representatives for:

- Develop, control, update and close-out country and site budgets (including Split site budget)
- Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
- Track and report contract negotiations
- Update and maintain contract templates (in cooperation with Legal Department)
- Calculate and execute payments (to investigators, vendors, grants)
- Ensure adherence to financial and compliance procedures
- Monitor and track adherence and disclosures
- Maintain tracking tools

**Meeting Planning**:

- Organize meetings (create & track study memos/letters/protocols)
- Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

**Quality & Oversight: (for Senior CTC level)**
- Contribute strongly to CTC team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
- Mentors / buddies junior CTCs (including, but not limited to process requirements)

**What you need to have**:
**Clinical Trial Coordinator (CTC)**
- Minimum 1-2 yrs in Clinical Research or relevant healthcare experience
- Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to
- work within these guidelines.
- Hands on knowledge of Good Documentation Practices
- ICH-GCP Knowledge appropriate to role
- Excellent negotiation skills for CTCs in finance area
- Highly effective time management, organizational and interpersonal skills, conflict management
- 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 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 taking full ownership of delegated tasks
- Proactive attitude to solving problems / proposing solutions
- To qualify, applicants must be legally authorized to work in Canada, and should not require, now or in the future, sponsorship for employment visa status

**Why ICON?**

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, reli

  • Clinical Trials Recruitment Coordinator

    6 months ago

    Montréal, Canada dicentra Full time

    Welcome to dicentra! Let’s build a better world, together! **Why join us** **Best workplace**: - We nourish an environment devoted to honesty and fairness, trust and respect. We care deeply for our team members and take work-life balance seriously, allowing our people to decide on a schedule that best fits their life and working preferences._ **Best...

  • Clinical Trials Recruitment Coordinator

    6 months ago

    Montréal, Canada dicentra Inc. Full time

    **Clinical Trials Recruitment Coordinator (Quebecois bilingual)** is responsible for recruitment of appropriate study participants for clinical research study visits and coordinating the recruitment process during clinical trials. CT Recruitment Coordinator is a key role in recruiting dedicated participants into clinical trials in a timely manner, and by...

  • Clinical Trial Coordinator-finance

    7 months ago

    Montréal, Canada Fortrea Full time

    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...

  • Clinical Trial Administrator

    7 months 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 Coordinator-finance

    7 months ago

    Montréal, Canada Fortrea Full time

    **Clinical Operations Manager - Finance** **Hybrid position** **Canada** We are seeking a** Clinical Trial Coordinator - Finance** to be responsible for site payments and budget negotiations, while being a core clinical trial team member with the client, as applicable. As a leading global contract research organization (CRO) with a passion for scientific...

  • Clinical Trial Coordinator-finance

    2 months ago

    Montréal, QC, Canada Fortrea Full time

    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. Conducting operations in...

  • Clinical Trial Coordinator

    7 months ago

    Montréal, Canada ICON Full time

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. **What you will be doing**: **Clinical Trial Coordinator (CTC)** **Trial and site...

  • Clinical Trial Assistant

    20 hours ago

    Montréal, Canada NeuroRx Research Full time

    **The role**:The Clinical Trial Assistant provides administrative support to all Project Managers in their daily duties, including liaising with clinical sites and MRI facilities. These duties include but are no limited to the following: - Submit requests for shipment of MRI supplies and trial-specific sFTP account creation - Issuing trial-specific...

  • Clinical Trial Assistant

    7 months ago

    Montréal, Canada NeuroRx Research Full time

    **The role**:The Clinical Trial Assistant provides administrative support to all Project Managers in their daily duties, including liaising with clinical sites and MRI facilities. These duties include but are no limited to the following: - Submit requests for shipment of MRI supplies and trial-specific sFTP account creation - Issuing trial-specific...

  • Clinical Trial Coordinator-finance

    7 months ago

    Montréal, Canada Fortrea Full time

    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...

  • Fsp - Clinical Project Manager

    4 hours ago

    Montréal, Canada Allphase Clinical Research Inc. Full time

    **Your responsibilities include, but are not limited to**: - Lead local evidence generation strategy and operations for key products/indications; - End-to-end management of local study design, analysis and communication of results for local client-sponsored studies; - Management of local research budget forecast, management and reconciliation; - Management...

  • Clinical Research Start-up Trial Manager

    7 months ago

    Montréal, Canada Translational Research in Oncology Full time

    Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today. TRIO is looking for a **Start-Up Manager **to join our **Strategy and Clinical...

  • Clinical Research Coordinator

    6 months ago

    Montréal, Canada Jewish General Hospital Full time

    **Jewish General Hospital (Lady Davis Institute)** **Clinical Research Unit of Radiation-Oncology** Working under the direction of the Principal Investigator (PI), the clinical research coordinator is responsible for supporting the successful conduct of clinical research studies in the radiation-oncology department. The focus of the clinical research...

  • Clinical Research Coordinator-coordonnateur(Trice)

    6 months ago

    Montréal, Canada Jewish General Hospital Foundation Full time

    **Clinical Research Coordinator Position** **Jewish General Hospital-Lady Davis Institute** **Functions**: Ø Takes knowledge of the protocol and gets familiar with all the different vendors of each clinical trial Ø Prepares a checklist for all the vendors and their links, for each clinical trial. Ø Prepares source documents. Ø Verifies eligibility...

  • Trial Master File Specialist

    7 months ago

    Montréal, Canada 35Pharma Inc. Full time

    **35Phama **is a clinical-stage biopharmaceutical company that designs and develops innovative therapeutics for life threatening lung diseases, and musculoskeletal and metabolic disorders. We believe in connecting rigorous science with our innate sense of urgency to rapidly generate breakthrough therapies for patients in need to better quality of life. Our...

  • French-speak Clinical Associate

    7 months ago

    Montréal, Canada Icon plc Full time

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Clinical Operations Manager

    4 weeks ago

    Montréal, QC, Canada Parexel Full time

    Parexel FSP is looking for a Clinical Operations Manager- FINANCE. The Clinical Operations Manager (COM)/Clinical Operations Manager Finance (COM-F)/ Clinical Operations Manager Regulatory (COM-R) is responsible for the following: • Performance and compliance for assigned protocols in a country in compliance with International Council for Harmonization...

  • Clinical Operations Manager

    7 months ago

    Montréal, Canada ICON plc Full time

    As a Clinical Operations Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: The Clinical Operations Manager is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to...

  • Clinical Research Coordinator

    4 months ago

    Montréal, QC, Canada Centre of Excellence in Thrombosis and Anticoagulation Care (CETAC) - Jewish General Hospital Full time

    **Job Summary**: Under the direction of Dr. Vicky Tagalakis and thrombosis clinical researchers Drs. Hirsch, Kahn and Simard, will perform duties associated with the day-to-day management of thrombosis clinical trials and observational studies conducted at the JGH site. This will involve recruitment and follow-up of patients, record keeping, and...

  • Clinical Research Associate

    7 months ago

    Montréal, Canada 35Pharma Inc. Full time

    **35Phama **is a clinical-stage biopharmaceutical company that designs and develops innovative therapeutics for life threatening lung diseases, and musculoskeletal and metabolic disorders. We believe in connecting rigorous science with our innate sense of urgency to rapidly generate breakthrough therapies for patients in need to better quality of life. Our...