Senior Project Coordinator / Coordonnateur principal de projet, North America

Role Summary

Description

The Senior Project Coordinator works with Project Managers, Clinical Trial Managers, Site Selection Team and Clinical Research Associates (CRA) to provide administrative and coordinating support for site activation activities and other site level deliverables through all phases of the clinical trial lifecycle. As a Senior Project Coordinator, you will take the lead to ensure timeframes, targets and the quality of the deliverables are in line with internal and external customer expectations. As a Senior member of the team, you work autonomously to ensure optimized site activation and maintenance and you may be asked to mentor junior project coordinators

More specifically, the Senior Project Coordinator

Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents.

Establishes site activation timelines with selected sites and coordinates activities to meet planned activation timelines.

Communicate with clinical sites during site start-up

Collaborates with other functional departments to ensure alignment of activities to meet site activation targets

Escalates to the Project Manager risks to site activation schedule.

Communicates directly with the study teams, external site staff, to ensure tasks and priorities are aligned to the defined study timelines.

Collects, reviews and files sites essential documents.

Ensures essential documentation is complete and of good quality to successfully first pass review for site activation

Ensures that the electronic Trial Master File (eTMF) contains the relevant regulatory documents for site activation and ongoing study management.

Collects and distributes documents from / to sites

Produces meeting minutes from project meetings.

Maintains ADI log.

Assigns documents for internal project-specific training and coordinates training reconciliation and documentation.

May assist with drafting of study documents and study plans for clinical trials.

Acts as a main point of contact for all site correspondences for non-protocol related issues.

Assists sites with local ethics submissions.

Assist internal and external teams with access to study-specific systems

Assist with initiating and maintaining study files.

Assist with assembling and shipping the Investigator’s Study File

Maintains project timeline dates, enrolment tracking tools, and study material inventory.

Prepares shipments of study supplies to clinical sites, when applicable.

Assists with preparation of Investigators’ Meeting

Distributes study correspondence to sites.

Serves as in-house contact to support CRAs when traveling.

Reviews and reconciles investigators site and vendor payments

Assists with project tracking activities and status reports preparation.

Participates in various administrative tasks as required to accomplish the goals of the project and the needs of the project team.

May support Health Authority inspection and pre-inspection activities.

May support audit preparation & Corrective Action / Preventative Action preparation for project related issues.

May perform project management duties on designated trials.

May mentor junior Project Coordinators and assist with onboarding activities.

May assist with process improvement and creation of training material within the Site Activation and Project Coordination department.

Ce poste est fait pour vous si

Vous avez un minimum de 2 ans d’expérience à titre de coordonnateur de projet ou dans un poste équivalent en recherche clinique, dans les secteurs biotechnologique, pharmaceutique ou en CRO.

Vous possédez une expérience avérée en démarrage de sites dans le cadre de la gestion d’essais cliniques et/ou d’équipes dans un environnement global ou multirégional.

Vous avez un intérêt pour l’administration de projets et la recherche clinique.

Vous souhaitez avoir un impact dans une entreprise en forte croissance.

Plus précisément, le coordonnateur principal de projet

Prépare les sites investigateurs à la conduite d’essais cliniques par la révision et l’approbation des documents essentiels et réglementaires.

Établit les échéanciers d’activation des sites sélectionnés et coordonne les activités nécessaires pour respecter ces échéanciers.

Communique avec les sites cliniques pendant la phase de démarrage.

Collabore avec d’autres départements fonctionnels pour assurer l’alignement des activités et le respect des objectifs d’activation.

Escalade les risques associés au calendrier d’activation des sites au chef de projet.

Communique directement avec les équipes d’étude et les intervenants des sites pour assurer l’alignement des tâches et des priorités avec les délais établis.

Recueille, révise et classe les documents essentiels des sites.

S’assure que la documentation essentielle est complète et de qualité suffisante pour passer la révision initiale avec succès.

Veille à ce que le fichier maître électronique (eTMF) contienne les documents réglementaires requis pour l’activation et la gestion continue de l’étude.

Recueille et distribue les documents aux sites et en provenance de ceux-ci.

Rédige les comptes rendus des réunions de projet.

Maintient à jour le registre ADI.

Attribue les documents pour les formations internes spécifiques aux projets et coordonne la documentation et la conciliation de ces formations.

Peut contribuer à la rédaction des documents d’étude et des plans d’étude.

Agit comme point de contact principal pour toute correspondance avec les sites ne touchant pas au protocole.

Assiste les sites dans leurs soumissions aux comités d’éthique locaux.

Soutient les équipes internes et externes pour l’accès aux systèmes spécifiques à l’étude.

Aide à l’initiation et à la tenue à jour des dossiers d’étude.

Contributes to assembling and sending the investigator's file.

Maintains timelines, enrollment tracking tools and inventory of study documents and materials up to date.

Prepares shipments of materials to clinical sites, when required.

Participates in the preparation of investigator meetings.

Distributes study correspondence to sites.

Serves as internal contact for support to CRAs on the move.

Verifies and reconciles payments from investigator sites and suppliers.

Contributes to project monitoring activities and the preparation of status reports.

Participates in various administrative tasks necessary to achieve project objectives and the needs of the project team.

May support health authority inspections and pre-inspection activities.

May contribute to the preparation of audits and corrective and preventive action plans (CAPA) for project-related issues.

May assume some project management responsibilities on designated trials.

May supervise junior project coordinators and participate in their integration activities.

May contribute to continuous process improvement and creation of training materials within the Project Coordination and Site Activation department.

Profile sought

Training

Bachelor's degree in a field relevant to clinical research or equivalent experience.

A post-graduate diploma specializing in drug development is an asset.

Requirements

This role will be perfect for you if

• You have a minimum of 2 years of experience as a Project Coordinator or equivalent position in clinical research and in the biotechnology, pharmaceutical, and/or CRO industry.
• You have proven Site Start-Up experience in the management of clinical trials and/or staff in a global/multi-regional environment.…
• You have an interest in project administration and clinical research;
• You want to have an impact in a fast-growing company.

Education

Bachelor’s degree in a field relevant to clinical research or equivalent experience.

Specialized graduate diploma in drug development is an asset

• Minimum of 2 years of experience as a Project Coordinator or equivalent position in clinical research and in the biotechnology, pharmaceutical, and/or CRO industry.
• Proven Site Start-Up experience in the management of clinical trials and/or staff in a global/multi-regional environment.…

Knowledge and skills

• Good knowledge of essential documentation requirements for clinical trials.
• Proficiency in English (written and oral) is required.
• Bilingual French and English or fluency in another European or Asian language is an asset.
• Excellent knowledge and competency in Word, Excel, and Power Point.
• Ability to prioritize multiple assignments to meet deadlines.
• Attention to detail. • Quick learner, good adaptability and versatile.
• Strong organizational, communication, problem-solving and multi-tasking skills.
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
• Minimum of 2 years of experience as a project coordinator or in an equivalent position in clinical research, in the biotechnology, pharmaceutical sectors or in a contract research organization (CRO).
• Proven experience in starting sites as part of managing clinical trials and/or teams in a global or multi-regional environment.

Knowledge and skills

• Good knowledge of essential documentary requirements for clinical trials.
• Fluency in English (written and oral) required.
• Bilingualism in French and English or mastery of another European or Asian language is an asset.
• Excellent command of Word, Excel and PowerPoint software.
• Ability to prioritize multiple tasks to meet deadlines.
• Attention to detail.
• Quick learner, good adaptability and versatility.
• Excellent organizational, communication, problem solving and multi-tasking skills.
• Good knowledge of Good Clinical Practices (GCP) as well as applicable Health Canada and Food and Drug Administration (FDA) regulations and guidelines.

About Indero , formely Innovaderm

Indero , formely Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero , formely Innovaderm continues to grow and expand in North America and Europe.

• Indero , formely Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero , formely Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
• Indero , formely Innovaderm only accepts applicants who can legally work in Canada

Description de poste

Le coordonnateur principal de projet travaille en collaboration avec les chefs de projet, les gestionnaires d’essais cliniques, l’équipe de sélection des sites et les associés de recherche clinique (ARC) afin d’offrir un soutien administratif et organisationnel pour les activités de mise en place des sites ainsi que pour d'autres livrables au niveau des sites, et ce, à toutes les phases du cycle de vie des essais cliniques. En tant que coordonnateur principal de projet, il prend les devants pour assurer que les échéanciers, les objectifs et la qualité des livrables répondent aux attentes des clients internes et externes. Membre senior de l’équipe, il travaille de manière autonome pour optimiser l’activation et le maintien des sites, et il peut être appelé à encadrer des coordonnateurs de projet juniors.

At Indero, you will work with competent and dynamic colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment as well as great prospects for professional development.

• In this position, you will benefit from the following conditions:
• Flexible work schedule
• Permanent full-time position
• Full range of benefits (medical, dental, vision insurance, retirement plan, vacation, personal days, virtual medical clinic, discounts on public transportation, social activities)
• Training and continuous development

Workplace

• The hired person will be able to work remotely from any city in Canada, or from our main office in Montreal (in accordance with company policies and public health directives).
• Occasional visits to our headquarters may be required or encouraged.

About Indero

Indero is a contract clinical research organization (CRO) specializing in clinical trials. Since its beginnings, our human-sized company has built a solid reputation for the quality of its research and services, surpassing the expectations of our clients. Based in Montreal, Indero continues its growth across North America and Europe.

• Indero is committed to providing fair treatment and equal opportunities to all applicants. Accommodations can be offered at any stage of the recruitment process for people with disabilities, upon request.
• Indero only accepts applications from individuals legally authorized to work in Canada.
• The masculine gender is used without discrimination, for the sole purpose of lightening the text.

About the Company

At Indero , formely Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

• As a Senior Project Coordinator, you will be eligible for the following perks:
• Permanent full-time position
• Flexible schedule
• Home-based position
• Ongoing learning and development