As a CRA (we are open to Jr. -1+ yrs or Sr. - 4+ yrs) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What you will be doing: Ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Study Monitoring Plan (CMP/SMP): Ability to conduct monitoring activities using different methods, e.g., both on-site and remote, where allowed by country regulations. Conducts Source Document Review and Source Data Verification of appropriate site source documents and medical records Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Manages reporting of protocol deviations and appropriate follow-up. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Manages reporting of identified issues and manages follow-up to resolution. Documents activities via follow-up letters, monitoring reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Study Monitoring Plan. Ensures all activities are managed by site personnel who are appropriately delegated and trained. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. Review Data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks. Review site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study review and assess training compliance with any new/updated training requirements (i.e., protocol amendment(s), etc.) Conduct Follow-up for Escalated AEM Report Query Check the site/external facilities, equipment and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable) Check site-specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, Investigational Product Accountability Log). Will collaborate with primary Site Manager who will act as the primary liaison with site personnel. Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. You are: Training and Education Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience Prior Experience 1+ years' experience as a CRA/Clinical Monitor with demonstrated monitoring experience. (virtual or onsite) Technical Competencies Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills Demonstrated networking and relationship building skills Ability to manage required travel Ability to communicate effectively and appropriately with internal & external stakeholders Ability to adapt to changing technologies and processes Demonstrated experience of utilising systems like Siebel CTMS, eTMF , eISF (Florence) OR can demonstrate skill sets that show they have agility to work with new systems to support monitoring practice Behavioral Competencies Effectively overcoming barriers encountered during the implementation of new processes and systems Identifies and builds effective relationships with investigator site staff and other stakeholders Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
As a Sr. CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What you will be doing: Ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Study Monitoring Plan (CMP/SMP): Ability to conduct monitoring activities using different methods, e.g., both on-site and remote, where allowed by country regulations. Conducts Source Document Review and Source Data Verification of appropriate site source documents and medical records Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Manages reporting of protocol deviations and appropriate follow-up. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Manages reporting of identified issues and manages follow-up to resolution. Documents activities via follow-up letters, monitoring reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Study Monitoring Plan. Ensures all activities are managed by site personnel who are appropriately delegated and trained. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. Review Data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks. Review site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study review and assess training compliance with any new/updated training requirements (i.e., protocol amendment(s), etc.) Conduct Follow-up for Escalated AEM Report Query Check the site/external facilities, equipment and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable) Check site-specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, Investigational Product Accountability Log). Will collaborate with primary Site Manager who will act as the primary liaison with site personnel. Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. You are: Training and Education Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience Prior Experience 5+ years experience as a CRA/Clinical Monitor with demonstrated monitoring experience in oncology (virtual or onsite) Technical Competencies Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills Demonstrated networking and relationship building skills Ability to manage required travel Ability to communicate effectively and appropriately with internal & external stakeholders Ability to adapt to changing technologies and processes Demonstrated experience of utilising systems like Siebel CTMS, eTMF , eISF (Florence) OR can demonstrate skill sets that show they have agility to work with new systems to support monitoring practice Behavioral Competencies Effectively overcoming barriers encountered during the implementation of new processes and systems Identifies and builds effective relationships with investigator site staff and other stakeholders Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Exciting remote opportunity for an eCOA PM with one of the world's leading CROs in ICON! Quebec is the preferred location but may be open to other provinces Job Description Summary The eCOA PM supports the implementation and management of Electronic Patient Reported Outcomes (ePRO) and other patient-focused technologies across Global Product Development. As a member of the Patient Technologies (PT) team within Information Management, this role contributes to developing processes, policies, and resources to enable clinical study teams to use assigned technologies efficiently, consistently, and with high quality while minimizing regulatory risk. The position takes ownership of sub-projects, engaging diverse stakeholders to ensure seamless adoption of ePRO and related solutions, including mobile applications, eConsent, and medical devices. This role requires both independent initiative and collaborative teamwork, with expertise in process development, technology deployment, and change management. What you will be doing: Serve as a key member of the Patient Technologies Team, driving development and maintenance of processes and technology tools for patient-based solutions. Act as a liaison to Information Management, Global Product Development, and Business/Research Units to identify and address needs for ePRO and Mobile Health support. Collaborate with cross-functional teams to influence decisions, resolve conflicts, and ensure alignment of patient technology initiatives. Support rapid response, audit, and inspection readiness related to patient-based technologies. Identify, develop, and implement solutions that enable study teams to effectively utilize ePRO, eConsent, and other patient-facing technologies. Lead or participate in standardization initiatives to optimize the use of patient technologies across the portfolio. Conduct research on emerging technologies and vendor services to expand organizational expertise and inform strategic planning. Your profile: Degree in a scientific, technology and/or business discipline, with 5+ years of working experience including 2 years of experience with Clinical Technologies. Good understanding of the processes associated with clinical study management, data management, and regulatory operations Familiarity with eConsent concepts and best practices. Demonstrated project management skills Project management, resource management (staff and financial), administrative, and technical capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization. Ability to manage multiple contacts and relationships at various levels throughout the organization Understanding of business process re-engineering and implementation planning Team player with good oral and written communication skills, with the ability to self-motivate on assigned sub-projects as required. Talent for training/presentation Self-starter who is able to work independently and willing to provide original thinking Adaptable and able to work with study teams with disparate levels of technical experience Understanding of current technology and how it could be used to facilitate growth toward overall corporate goals Ability to keep abreast of current regulatory and technical trends and how these trends would impact patient technology implementation within a large sponsor organization At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request.
As a Sr. CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What you will be doing: Ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Study Monitoring Plan (CMP/SMP): Ability to conduct monitoring activities using different methods, e.g., both on-site and remote, where allowed by country regulations. Conducts Source Document Review and Source Data Verification of appropriate site source documents and medical records Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Manages reporting of protocol deviations and appropriate follow-up. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Manages reporting of identified issues and manages follow-up to resolution. Documents activities via follow-up letters, monitoring reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Study Monitoring Plan. Ensures all activities are managed by site personnel who are appropriately delegated and trained. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. Review Data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks. Review site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study review and assess training compliance with any new/updated training requirements (i.e., protocol amendment(s), etc.) Conduct Follow-up for Escalated AEM Report Query Check the site/external facilities, equipment and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable) Check site-specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, Investigational Product Accountability Log). Will collaborate with primary Site Manager who will act as the primary liaison with site personnel. Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. You are: Training and Education Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience Prior Experience 5+ years experience as a CRA/Clinical Monitor with demonstrated monitoring experience in oncology (virtual or onsite) Technical Competencies Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills Demonstrated networking and relationship building skills Ability to manage required regional travel Ability to communicate effectively and appropriately with internal & external stakeholders Ability to adapt to changing technologies and processes Demonstrated experience of utilising systems like Siebel CTMS, eTMF, eISF (Florence) OR can demonstrate skill sets that show they have agility to work with new systems to support monitoring practice Behavioral Competencies Effectively overcoming barriers encountered during the implementation of new processes and systems Identifies and builds effective relationships with investigator site staff and other stakeholders Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
As a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. We are searching for a CRA to monitor a high enrolling site in Rimouski. We are open to junior (1+ yrs) or senior (4+ yrs) levels. What you will be doing: Ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Study Monitoring Plan (CMP/SMP): Ability to conduct monitoring activities using different methods, e.g., both on-site and remote, where allowed by country regulations. Conducts Source Document Review and Source Data Verification of appropriate site source documents and medical records Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Manages reporting of protocol deviations and appropriate follow-up. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Manages reporting of identified issues and manages follow-up to resolution. Documents activities via follow-up letters, monitoring reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Study Monitoring Plan. Ensures all activities are managed by site personnel who are appropriately delegated and trained. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. Review Data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks. Review site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study review and assess training compliance with any new/updated training requirements (i.e., protocol amendment(s), etc.) Conduct Follow-up for Escalated AEM Report Query Check the site/external facilities, equipment and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable) Check site-specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, Investigational Product Accountability Log). Will collaborate with primary Site Manager who will act as the primary liaison with site personnel. Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. You are: Training and Education Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience Prior Experience 1+ years' experience as a CRA/Clinical Monitor with demonstrated monitoring experience. (virtual or onsite) Technical Competencies Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills Demonstrated networking and relationship building skills Ability to manage required travel Ability to communicate effectively and appropriately with internal & external stakeholders Ability to adapt to changing technologies and processes Demonstrated experience of utilising systems like Siebel CTMS, eTMF , eISF (Florence) OR can demonstrate skill sets that show they have agility to work with new systems to support monitoring practice Behavioral Competencies Effectively overcoming barriers encountered during the implementation of new processes and systems Identifies and builds effective relationships with investigator site staff and other stakeholders Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
As a CRA you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence. En tant qu’ARC (Associé(e) de recherche clinique), vous rejoindrez la plus grande et la plus complète organisation de recherche clinique au monde, propulsée par l’intelligence en santé. What you will be doing: Conduct clinical trial site visits including evaluation, initiation, monitoring and close out Oversee and report on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systems Proactive site management including: Building and maintaining solid and professional relationships with site staff Facilitating subject enrolment incorporating recruitment strategies and action plans at site level Maintaining site audit/inspection readiness Ensuring appropriate safety reporting and use of on-line safety reporting/reviewing systems such as Intralinks Verification of electronic case report form data against written and electronic source documentation as per study schema/monitoring plan Responding to site queries and escalating issues in accordance with processes and timelines Conducting IP accountability and reconciliation Facilitating implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting) Maintenance of site study supplies Operational Excellence: Contribute to sponsor goals Promote operational and scientific excellence Identify opportunities and best practices with local/regional partners that will contribute to the overall operational effectiveness. Gestion des sites d’essais cliniques Effectuer des visites de sites d’essais cliniques : incluant l’évaluation, l’initiation, la surveillance et la clôture. Superviser et rendre compte de la conduite des essais cliniques : au niveau du site, y compris les rapports de visites en ligne et les mises à jour des systèmes de gestion électroniques. Gestion proactive des sites, incluant : Établir et maintenir des relations solides et professionnelles avec le personnel du site. Faciliter l’enrôlement des sujets en intégrant des stratégies de recrutement et des plans d’action au niveau du site. Maintenir la préparation à l’audit/inspection du site. Assurer la déclaration appropriée des événements indésirables et l’utilisation des systèmes de déclaration/évaluation en ligne tels qu’Intralinks. Vérifier les données des formulaires électroniques de rapport de cas (eCRF) par rapport à la documentation source écrite et électronique, conformément au schéma de l’étude/plan de surveillance. Répondre aux questions du site et escalader les problèmes conformément aux processus et délais. Effectuer la responsabilité et la réconciliation des produits de l’essai (IP). Faciliter la mise en œuvre de nouvelles technologies et systèmes sur les sites cliniques (Collecte de données électronique, déclaration eSAE). Maintenir les fournitures d’étude du site. Excellence opérationnelle Contribuer aux objectifs du promoteur. Promouvoir l’excellence opérationnelle et scientifique. Identifier les opportunités et les meilleures pratiques avec les partenaires locaux/régionaux qui contribueront à l’efficacité opérationnelle globale. You are: BA/BS/BSc in the sciences or nursing equivalent A trained CRA with on-site monitoring experience Comprehensive knowledge and understanding of ICH-GCP Fluent oral (face to face and telephone) and written English language skills Able and willing to travel up to 60% of the time or as per local requirements Possession of a full driver’s license Able and willing to work from a designated and appropriate home office as per local requirements Willing to attend and contribute to team meetings including mandatory training (remote/off-site) Competent computer skills including working knowledge of common software packages Working knowledge of trial management databases and on-line systems Able to attend a 1 week face to face in-house training course as part of on-boarding training Able and willing to work on several protocols/therapy areas Experience in phase II and phase III trials (preferred) Working knowledge of Electronic Data Capture (preferred) Experience/working knowledge of the oncology disease area (preferred) Experience of Centralized/Risk Based/Targeted monitoring (preferred) Experience of working within a metric based environment (preferred) Diplôme universitaire en sciences de la vie ou en soins infirmiers (équivalent d'un BA/BS/BSc). Certification d'infirmier(ère) autorisé(e) (RN) ou qualification académique/ professionnelle équivalente. Expérience préalable en surveillance clinique sur site, généralement de 1 à 2 ans. Connaissance approfondie des Bonnes Pratiques Cliniques (BPC/ICH-GCP) et des réglementations locales. Compétences en communication orale et écrite en anglais, avec une maîtrise des termes médicaux.
As a CRA you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence. What You’ll Be Doing: Serve as the primary point of contact between investigational sites and the sponsor Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out Ensure site compliance with ICH-GCP, SOPs, and Health Canada regulations Maintain up-to-date documentation in CTMS and eTMF systems Support and track site staff training and maintain compliance records Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting Support subject recruitment and retention efforts at the site level Oversee drug accountability and ensure proper storage, return, or destruction Resolve data queries and drive timely, high-quality data entry Document site progress and escalate risks or issues to the clinical team Assist in tracking site budgets and ensuring timely site payments (as applicable) Collaborate with cross-functional partners including CTAs, LTMs, and CTMs You are: Based in Vancouver, British Columbia Eligible to work in Canada without visa sponsorship A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry Experienced across multiple therapeutic areas, ideally including Oncology, Hematology, Prostate Cancer, Lung Cancer, and Early Phase/Phase 1 A graduate with a Bachelor’s degree in Life Sciences or equivalent, or a qualified RN Knowledgeable in Health Canada regulations and working with Research Ethics Boards (REBs) Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF A clear communicator, problem-solver, and collaborative team player Willing and able to travel approximately 50% for on-site monitoring visits
