24 Medical Researchers jobs in Toronto

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 organisation, powered by healthcare intelligence.

What you will be doing:

• Oversee multiple oncology trials, ensuring high-quality execution
• Provide leadership and mentorship to junior flex team members
• Act as Lead SM, training and guiding other Site Managers on study protocols
• Develop essential study start-up documents, including SIV agendas
• Represent Site Managers and Lead Trial Managers (LTMs) in key meetings
• Ensure the SM perspective is reflected in study documents like Monitoring Guidelines
• Review reports (SQV, SMV, SCV) for sites assigned to other SMs within the same trial
• Support country budget development and contract negotiations in collaboration with CCS colleagues
• Assist with ASV activities and ensure alignment with study objectives
• Maintain compliance with Metrics/KPIs as outlined in the Quality Oversight Plan (QOP)

You Are:

• Remote position located in Toronto, Canada
• Minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
• At least 2 years of experience monitoring clinical trials in the pharmaceutical industry
• Knowledge of several therapeutic areas is an asset, including oncology – preferably Hematology, Prostate Cancer, Lung Cancer, Early development (Phase 1) etc.
• Knowledge of risk-based/analytical monitoring approaches is an asset
• Proficiency in clinical trial systems such as CTMS, EDC, TMF, IWRS, and safety reporting tools
• Ability to actively drive patient recruitment strategies at assigned sites
• Strong collaboration with investigators and site staff to meet study timelines
• Effective communication and influencing skills to manage study sites effectively, both remotely and in-person
• Ability to work independently while being a strong collaborator
• In-depth understanding of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements
• Up to 50% regional travel required
• 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

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:

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, 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 here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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

What you will be doing:

• Oversee multiple oncology trials, ensuring high-quality execution
• Provide leadership and mentorship to junior flex team members
• Act as Lead SM, training and guiding other Site Managers on study protocols
• Develop essential study start-up documents, including SIV agendas
• Represent Site Managers and Lead Trial Managers (LTMs) in key meetings
• Ensure the SM perspective is reflected in study documents like Monitoring Guidelines
• Review reports (SQV, SMV, SCV) for sites assigned to other SMs within the same trial
• Support country budget development and contract negotiations in collaboration with CCS colleagues
• Assist with ASV activities and ensure alignment with study objectives
• Maintain compliance with Metrics/KPIs as outlined in the Quality Oversight Plan (QOP)

You Are:

• Remote position located in Toronto, Canada
• Minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
• At least 2 years of experience monitoring clinical trials in the pharmaceutical industry
• Knowledge of several therapeutic areas is an asset, including oncology – preferably Hematology, Prostate Cancer, Lung Cancer, Early development (Phase 1) etc.
• Knowledge of risk-based/analytical monitoring approaches is an asset
• Proficiency in clinical trial systems such as CTMS, EDC, TMF, IWRS, and safety reporting tools
• Ability to actively drive patient recruitment strategies at assigned sites
• Strong collaboration with investigators and site staff to meet study timelines
• Effective communication and influencing skills to manage study sites effectively, both remotely and in-person
• Ability to work independently while being a strong collaborator
• In-depth understanding of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements
• Up to 50% regional travel required
• 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

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:

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, 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 here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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'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
**Ce Que Vous Ferez:**
+ Servir de point de contact principal entre les sites d'études et le promoteur
+ Effectuer tous les types de visites sur site, y compris la sélection, l'initiation, la surveillance de routine et la clôture
+ Assurer la conformité du site aux normes ICH-GCP, aux SOPs et aux règlements de Santé Canada
+ Maintenir la documentation à jour dans les systèmes CTMS et eTMF
+ Soutenir et suivre la formation du personnel du site et tenir les dossiers de conformité à jour
+ Surveiller la sécurité des patients, en assurant un signalement rapide et précis des AE/SAE/PQC
+ Appuyer les efforts de recrutement et de rétention des participants à l'étude au niveau du site
+ Superviser la gestion des médicaments, y compris leur entreposage, leur retour ou leur destruction appropriée
+ Résoudre les requêtes de données et encourager une saisie de données rapide et de haute qualité
+ Documenter l'avancement du site et signaler tout risque ou problème à l'équipe clinique
+ Contribuer au suivi du budget du site et veiller aux paiements rapides (le cas échéant)
+ Collaborer avec les partenaires interfonctionnels, incluant les CTA, LTM et CTM
**You are:**
+ Based in Greater Toronto Area
+ 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
**Vous êtes:**
+ Basé(e) dans la région du Grand Toronto
+ Autorisé(e) à travailler au Canada sans parrainage de visa
+ Un(e) professionnel(le) de la recherche clinique avec plus de 2 ans d'expérience en surveillance sur site dans l'industrie pharmaceutique ou auprès d'une CRO
+ Expérimenté(e) dans plusieurs aires thérapeutiques, idéalement en oncologie, hématologie, cancer de la prostate, cancer du poumon et en phases précoces / Phase 1
+ Titulaire d'un baccalauréat en sciences de la vie ou d'un diplôme équivalent, ou infirmier(ère) autorisé(e) (IA)
+ Connaissant bien les règlements de Santé Canada et le travail avec les comités d'éthique de la recherche (CER)
+ Maîtrisant les ICH-GCP, les exigences réglementaires locales et les systèmes cliniques comme le CTMS et le eTMF
+ Un(e) communicateur(trice) clair(e), apte à résoudre des problèmes et collaboratif(ve) au sein d'une équipe
+ Prêt(e) et capable de voyager environ 50 % du temps pour des visites de surveillance sur site
**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: 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, colour, 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 through the form below.
in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

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 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.