8 meilleures offres (clinical trial monitor, mississauga, on) (à pourvoir)

Lead Clinical Research Associate
PSI CRO —Toronto, ON
- De 124 000 $ à 153 000 $ par an
- Temps plein
- Télétravail
- Anglais
- Microsoft Office
- Baccalauréat
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il y a 1 jour
responsable clinique / Clinical Lead
IQVIA —Mississauga, ON
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- Microsoft Powerpoint
- Microsoft Word
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Clinical Research Coordinator III (Nurse)
University Health Network —Toronto, ON
- De 84 779 $ à 105 968 $ par an
- Contrat
- Expérience en laboratoire
- Baccalauréat
- Compétences en communication
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il y a 8 jours
Scientist II - Analytical Operations
Thermo Fisher Scientific —Mississauga, ON
- De 62 000 $ à 93 050 $ par an
- Temps plein
- Microsoft Word
- Microsoft Excel
- Expérience en laboratoire
- Jours fériés payés
- Assurance Dentaire
Senior Clinical Research & Medical Affairs Specialist
Mimosa Diagnostics —Toronto, ON
- Temps plein
- Travail hybride
- Soins infirmiers
- Microsoft Excel
- Maîtrise
- Assurance Dentaire
- Assurance Vision
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Clinical Data Collection Manager
Oncoustics —Toronto, ON
- Temps plein
- Maîtrise
- Bases de données
- Baccalauréat
Sr. Manager, Site Budgets & Contracts
Moderna, Inc. —Toronto, ON
- Temps plein
- Microsoft Excel
- Microsoft Office
- Déplacements à prévoir
- Jours fériés payés
- Congés payés
Associate Director, Clinical Operations (Study Startup)
Everest Clinical Research —Canada
- De 165 000 $ à 210 000 $ par an
- Télétravail
- Expérience en gestion
- Déplacements à prévoir jusqu'à 50%
- Maîtrise
- Assurance Invalidité
- Assurance Dentaire
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Clinical Trial IWRS Monitor (Overnight)
Everest Clinical Research —Markham, ON
Execute CTT application test planning, test plan, and test script development and Stage I and II testing activities for CTT applications (newly developed…
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Senior Clinical Trial IWRS Monitor
Everest Clinical Research —Markham, ON
At least four or more years of experience in clinical trial data processing, technology delivery, process analysis and design, software development lifecycle,…
De 70 000 $ à 90 000 $ par an
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Lead Clinical Research Associate

PSI CRO -
Toronto, ON

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Détails du poste

Temps plein
De 124 000 $ à 153 000 $ par an
Il y a 1 jour

Profil recherché

Anglais
Microsoft Office
Baccalauréat
Permis de conduire

Description complète du poste

Company Description

PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

Coordinates investigator/ site feasibility and identification process, as well as study startup.
Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
Manages Monitors in the query resolution process, including Central Monitoring observations.
Coordinates safety information flow and protocol/process deviation reporting.
Performs clinical supplies management with vendors on a country and regional level.
Ensures study-specific and corporate tracking systems are updated in a timely manner.
Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
Coordinates planning of supervised monitoring visits and conducts the visits.
Manages the project team in site contracting and payments.
Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
Ensures ongoing evaluation of data integrity and compliance at a country/regional level.
Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
Oversees project team in CAPA development and implementation.
Coordinates project team in process deviations review, management and reporting.
Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
Delivers trainings and presentations at Investigator Meetings.
Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.
Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
Ensures data integrity and compliance at a site level.
Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
Conducts project-specific training of site Investigators.
Supports preparation of draft regulatory and ethics committee submission packages.

Qualifications

Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level.
Must have prior experience monitoring or managing sites and CRAs with knowledge of US and Canadian regulatory guidelines and practices.
Experience with all types of monitoring visits in Phases I-III.
Strong experience in Oncology preferred.
Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred.
Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred.
Full working proficiency in English.
Proficiency in MS Office applications.
Ability to plan, multitask and work in a dynamic team environment.
Excellent Communication, collaboration, and problem-solving skills.
Ability to travel up to 65% (depending on project needs).
Valid driver’s license (if applicable).

Additional Information

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company that puts its people first.

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clinical trial monitor emplois - mississauga, on

Lead Clinical Research Associate

responsable clinique / Clinical Lead

Clinical Research Coordinator III (Nurse)

Scientist II - Analytical Operations

Senior Clinical Research & Medical Affairs Specialist

Clinical Data Collection Manager

Sr. Manager, Site Budgets & Contracts

Associate Director, Clinical Operations (Study Startup)

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