314 Healthcare Research jobs in Canada

Clinical Research Associate, Toronto, Canada, Oncology Required
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.
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:**
+ Contribute to the identification of new sites for clinical trials
+ Assume ambassadorial role to facilitate communication between sites and sponsor CPO to increase value proposition to investigators.
+ Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the Clinical Study Manager in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.
+ Execute site initiation and training, generate initiation visit report.
+ Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
+ Identify problems at sites; resolve issues and escalate as appropriate.
+ Complete preparation and generation of visit monitoring reports as per relevant SOP.
+ Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
+ Implement site close-out activities and generate site close-out report.
+ Provide feedback on site performance for future trial site feasibility/selection
+ Improve skills by timely completion performance of assigned global and local training.
+ **Responsabilités:**
+ Contribuer à l'identification de nouveaux centres pour des études cliniques
+ Assumer un rôle d'ambassadeur pour faciliter les communications entre les centres d'étude et le Directeur de l'expérience patient du promoteur, afin de rehausser la proposition de valeur aux chercheurs.
+ Faciliter la préparation et la collecte des documents aux centres d'étude et à l'échelle du pays pendant toutes les phases d'étude. Soutenir le travail du gestionnaire de l'étude clinique pour la surveillance des fichiers maîtres de l'étude (FME) aux centres d'étude et à l'échelle du pays. Pendant toutes les phases d'étude, s'assurer que l'archivage est conforme aux procédures d'exploitation normalisées.
+ Effectuer l'initiation des centres d'étude et la formation du personnel, rédiger le rapport de la visite d'initiation.
+ Mettre en place la structure complète de gestion des centres d'étude, entre autres, les visites de surveillance, les évaluations réglementaires, la gestion de l'approvisionnement en médicaments, pour assurer la conformité au protocole, aux BPC, aux réglementations mondiales et locales, et aux processus mondiaux et locaux.
+ Identifier les problèmes aux centres d'étude; résoudre les problèmes et les communiquer à un palier supérieur de la direction, le cas échéant.
+ Effectuer la rédaction complète et la distribution des rapports sur les visites de surveillance, conformément aux procédures d'exploitation normalisées pertinentes.
+ Examiner et gérer continuellement les données recueillies aux centres d'étude, afin de résoudre rapidement les problèmes techniques et de contenu pour atteindre les cibles de verrouillage de la base de données en temps opportun.
+ Mettre en œuvre les activités de clôture des centres d'étude et rédiger le rapport de clôture des centres d'étude.
+ Fournir des commentaires sur les performances des centres d'étude afin d'évaluer leur candidature pour de futures études cliniques.
**Your Profile:**
+ Bachelor's Degree or higher in life sciences or equivalent
+ Minimum 2 years' clinical site monitoring experience from CRO or Pharmaceutical company
+ Comprehensive knowledge and understanding of ICH-GCP
+ Able and willing to travel up to 60% regionally (sites in Quebec City and Montreal)
+ Able and willing to work on several protocols/therapy areas
+ Experience in phase I-IV trials
+ Working knowledge of Electronic Data Capture (preferred)
+ Experience/working knowledge of the oncology disease area (preferred but not required)
+ Experience of Centralized/Risk Based/Targeted monitoring (preferred)
+ Experience of working within a metric based environment (preferred)
+ Excellent attention to detail
+ Highly developed time management and organizational skills
+ Focused on meeting study deliverables/targets
+ Flexible and willing to adapt to changing priorities/timelines
+ Experience in oncology is required
+ Blingual English/French Required
**Compétences**
+ Baccalauréat ou diplôme supérieur en sciences de la vie ou un équivalent
+ Minimum de 2 à 4 ans d'expérience en surveillance de centres d'étude pour une entreprise de recherche contractuelle ou une société pharmaceutique
+ Des connaissances et une compréhension approfondies des bonnes pratiques cliniques élaborées par la Conférence internationale sur l'harmonisation (BPC-CIH)
+ Bilinguisme français/anglais (maîtrise verbale et écrite) exigé
+ Disposé(e) et apte à voyager jusqu'à 60 % du temps à l'échelle régionale (centres d'étude à Québec et à Montréal)
+ Disposé(e) et apte à travailler sur plusieurs protocoles/domaines thérapeutiques
+ Expérience dans les études cliniques de phase I à IV
+ Connaissance pratique de la saisie électronique des données (préférable)
+ Expérience/connaissance pratique dans le domaine des maladies oncologiques (préférable, mais non requise)
+ Expérience dans la surveillance centralisée/axée sur les risques/ciblée (préférable)
+ Expérience de travail dans un environnement métrique (préférable)
+ Souci du détail
+ Compétences organisationnelles et de gestion du temps de haut niveau
+ Déterminé(e) à fournir les livrables et atteindre les objectifs des études
+ Flexible et disposé(e) à s'adapter aux changements dans les priorités/échéanciers
**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 maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
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 here ( 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.
Are you a current ICON Employee? Please click here ( to apply

Job Description

Job Description

Salary: $80,000-$00,000

Acuitas Therapeutics is a private biotechnology company located at 6190 Agronomy Rd #402, Vancouver,British Columbia, Canada. We are the premier global provider of LNP delivery systems for nucleic acid therapeutics. Acuitas is partnered with multiple international, biotechnology and pharmaceutical partners who are focused on bringing new vaccines and drugs into clinical development and to the marketplace.

At Acuitas, we believe in combining excellent science with an enviable work culture. The advanced LNP technologies we provide for our partners are made possible by our employees who apply their passion, curiosity, and knowledge every step of the way. At Acuitas, you will have the opportunity to work as part of a close-knit team of exceptional scientists, who support the production of revolutionary technology that impacts the health and wellness of society. By living our values, including honesty, integrity, innovation and openness, we have fostered a supportive work environment where our employees feel empowered, challenged, recognized and rewarded. If you would like to work for a company that is at the top of the field, Acuitas is the company for you!

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or any other status protected by applicable law.

Job Title: Research Associate, Preclinical

YOU: A committed professional with experience in preclinical research looking to develop further in an innovative, fast paced biotech environment.

US: Leading innovators in the lipid nanoparticle (LNP) field, looking for a talented individual to join our collaborative, passionate, and diverse results focused team.

ROLE SUMMARY: Acuitas Therapeutics is seeking a permanent, full-time Research Associate with a strong background in immunology and immunological methods to work in the Preclinical team, reporting to the Senior Research Scientist, Preclinical. The role holder will be responsible for executing and supporting studies assessing the pharmacology, immunology, mechanism of action, distribution and safety profile of our LNP, executing analyses and data interpretation, and presenting results to the team and company.

Working with the Preclinical team, the responsibilities would include:

1. Executing and supporting studies to evaluate LNP activity, distribution, mechanisms of action, immune profiles and safety.
2. Mastering established methods and developing new methods to support preclinical objectives, including ELISA, MSD, luciferase assays, qPCR, SDS-PAGE, DNA/RNA isolation and protein quantification.
3. Cell culture and cell-based assays (including ELIspot), cell isolation, and processing tissues and fluids for downstream analysis.
4. Hands-on experience in multi-colour flow cytometry, intracellular cytokine staining and gating strategies.
5. General laboratory support including preparation of reagents and solutions, laboratory organization, maintaining sample and reagent inventory, and shipping of materials.
6. Up to date Biosafety/Biosecurity (Containment Level 2+) and WHMIS certification will be required.
7. Maintain familiarity with relevant scientific knowledge and advancements in LNP technology.
8. May be required to train more junior staff and co-op students.

QUALIFICATIONS AND SKILLS:

• BSc with 2-10 years experience or an MSc with up to 7 years experience; some industry experience preferred.

• Hands-on experience conducting experiments with LNP in vitro and ex vivo; knowledge of LNP formulation processes, LNP characteristics, in vivo biodistribution, pharmacodynamics and pharmacokinetics
• Strong background in innate and adaptive immunology. Knowledge specific to LNP preferred.
• Strong understanding of cell biology and human physiology with a focus on liver structure and function as well as other fenestrated organs.
• Background in vaccine development and experience conducting/analyzing associated assays (ELISA, EliSpot, HAI)
• Hands-on experience in tissue isolation, single cell preparation, cell culture, cell-based assays and cell differentiation.
• Extensive experience in multiplex immune-based assays. Specifically Meso Scale Diagnostics and multichannel flow cytometry including the development of gating strategies.
• Confident and proven safety when working in Biosafety Level 2+ environments.
• Excellent writing and presentation skills. Accurate and appropriate data analysis and use of statistics.
• Familiar with Spotfire and Big Omics or similar visualization platforms. Fluent working with Graph Pad and Microsoft Office. Adept utilizing Flo Jo or similar.
• Responsible and reliable record keeping, organization and assisting in lab management as needed.
• Very strong communicator in English language

Benefits
Health benefits
Dental plan
Disability benefits
Health care plan
Paramedical services coverage
Vision care benefits

Financial benefits
Bonus
Group insurance benefits
Life insurance
Registered Retirement Savings Plan (RRSP)
Long term benefits
Maternity and parental benefits
Other benefits
Learning/training paid by employer
On-site amenities
Paid time off (volunteering or personal days)

Compensation

80,000- 100,000 per annum

Contact:

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.

**Research Associate**
**Infrastructure Insights**
**Location:** Canada
**Work mode:** Home Based - Hybrid
**Position Summary:**
The **Research Associate - Infrastructure Insights** plays a key role in advancing Bentley's mission to inform and inspire positive change across the global infrastructure ecosystem. Sitting within the Infrastructure Policy & Advocacy (IPA) initiative, this role leads industry-insight monitoring and reporting for Bentley's leadership team.
You will design and manage a scalable research process to identify and track emerging trends in infrastructure markets, develop productive relationships with industry membership bodies, and deliver quarterly data-driven reports that help shape Bentley's strategic direction. This position offers the opportunity to collaborate across teams and ensure research outputs are accessible, inclusive, and aligned with Bentley's commitment to sustainability, innovation, and equity.
_Note: This role is internally titled_ **_Infrastructure Insights Lead_** _, reflecting its strategic scope and leadership responsibilities within the IPA initiative._
**Responsibilities:**
+ Lead the IPA's industry-insight monitoring and reporting function, developing a scalable process for market research and reporting that can grow across regions and business functions.
+ Conduct desk-based research and engage stakeholders - including industry associations and relevant bodies - to analyze:
+ Global developments across infrastructure sectors (transport, water, energy, etc.)
+ Infrastructure policy and investment trends in Bentley's key markets
+ Innovative funding, finance, and delivery models
+ Digital transformation trends in infrastructure
+ Synthesize research findings into quarterly insight reports, briefing notes, market scans, and landscape analyses to support Bentley's programs and partnerships.
+ Develop and maintain a knowledge base of relevant data sources, stakeholders, and industry initiatives, ensuring insights are accurate, timely, and broadly accessible to internal stakeholders.
+ Collaborate with cross-functional teams to support inclusive decision-making and knowledge sharing.
**Qualifications:**
+ Bachelor's degree in public policy, management, engineering, urban planning, economics, or a related field; Master's degree preferred but not required.
+ 5+ years of experience in research, consulting, or policy analysis, ideally within infrastructure or the built environment.
+ Strong analytical and critical thinking skills, with the ability to synthesize complex information into clear, actionable insights.
+ Excellent written and verbal communication skills in English (near-native fluency required); additional languages are a plus.
+ Self-starter with strong organizational skills, attention to detail, and a collaborative mindset.
+ Familiarity with infrastructure markets, public policy, and international business - or the ability to quickly learn and adapt.
+ Commitment to Bentley's values, including sustainability, innovation, and fostering an inclusive workplace.
+ We encourage candidates from diverse backgrounds to apply, even if you do not meet 100% of the listed qualifications.
**What We Offer:**
+ A great Team and culture - please see our colleague video .
+ An exciting career as an integral part of a world-leading software company providing solutions for architecture, engineering, and construction - watch this short documentary about how we got our start.
+ An attractive salary and benefits package.
+ A commitment to inclusion, belonging and colleague wellbeing through global initiatives and resource groups.
+ A company committed to making a real difference by advancing the world's infrastructure for better quality of life, where your contributions help build a more sustainable, connected, and resilient world. Discover our latest user success stories for an insight into our global impact.
**LI-BC #LI-Hybrid #LI-Remote**
 **About Bentley Systems**
Around the world, infrastructure professionals rely on software from Bentley Systems to help them design, build, and operate better and more resilient infrastructure for transportation, water, energy, cities, and more. Founded in 1984 by engineers for engineers, Bentley is the partner of choice for engineering firms and owner-operators worldwide, with software that spans engineering disciplines, industry sectors, and all phases of the infrastructure lifecycle. Through our digital twin solutions, we help infrastructure professionals unlock the value of their data to transform project delivery and asset performance. Opportunity Employer:**
Bentley is proud to be an equal opportunity employer and considers for employment all qualified applicants without regard to race, color, gender/gender identity, sexual orientation, disability, marital status, religion/belief, national origin, caste, age, or any other characteristic protected by local law or unrelated to job qualifications.
Equal Opportunity Employer/Minorities/Females/Veterans/Disabled

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
R&D Operations
**Job Sub** **Function:**
Clinical Trial Support
**Job Category:**
Professional
**All Job Posting Locations:**
Toronto, Ontario, Canada
**Job Description:**
**About Innovative Medicine**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at are searching for the best talent for an **Associate Site Manager (Clinical Research Associate)** . This position is a field-based role covering primarily the Greater Toronto Area, Ontario; occasional travel outside of this province as needed _._ Ideally, the Associate Site Manager should be located in the Greater Toronto Area.
**Purpose:**
As an Associate Site Manager (Clinical Research Associate), you will be part of the Global Clinical Operations (GCO) Canada team and will be responsible for study site management through the assessment/selection, initiation, maintenance and closure phases of a clinical trial (Phase 1 - 4 trials).
**You will be responsible for:**
+ You are the primary point of contact for the study site; liaison with study teams.
+ Your responsibilities include actively identifying and driving patient recruitment strategies at assigned sites.
+ You are responsible for monitoring the study/site according to GCP standards and J&J GCO SOPs, both on-site and with remote contacts. This includes source document verification, Investigator Site File (ISF) review and accurate drug accountability.
+ You will provide site training, during site initiation and ongoing, to ensure compliance with all required regulations, SOPs, trial-specific tools and systems, and specialized procedures.
+ You will ensure resolution of site-specific issues and will partner closely with investigator and site staff to meet all study timelines.
+ You will work closely with the local study operations team to resolve protocol and site-specific issues.
+ You will use and maintain the clinical trial tracking system (CTMS) and update the electronic Trial Master File (TMF) as required.
**Qualifications / Requirements:**
+ Bachelor of Science, R.N., or equivalent degree in Biological Sciences preferred.
+ Minimum of 1 year experience in onsite and offsite (remote) monitoring; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.
+ Pharmaceutical industry clinical research trial experience preferred.
+ Analytical/risk-based monitoring experience is highly preferred.
+ Knowledge of several therapeutic areas is an asset (preferably including oncology).
+ In-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
+ Ability to operate and use various systems and databases (e.g., CTMS, EDC, TMF, various dashboards/metrics, IWRS, safety reporting).
+ Strong communication and influencing skills to effectively manage study sites both remotely and face-to-face.
+ Strong team member and self-starter with the ability to work independently.
+ Ability to establish a home office.
+ Fluent in the English language.
+ Travel: 30-50%. Onsite monitoring visits will be conducted in combination with offsite (remote) monitoring visits. You will be assigned sites mainly within your region/province, with occasional need for travel to neighboring provinces.

The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.
**Monitoring Responsibilities and Study Conduct:**
+ Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality
+ Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
+ During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
+ Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
+ Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
+ Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level
+ Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
+ Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
+ Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
+ Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
+ Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
+ Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
+ Support database release as needed
+ May undertake the responsibilities of an unblinded monitor where appropriate
**Clinical/Scientific and Site Monitoring Risk:**
+ Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
+ Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals
+ Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
+ Drive Quality Event (QE) remediation, when applicable
+ Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
**Skills:**
+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
+ Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
+ Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
+ Must be fluent in English and in the native language(s) of the country they will work in
+ Ability to travel 60-80%
+ Valid driver's license and passport required
**Education:**
+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
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#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.