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Clinical research • sherbrooke qc

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Senior CRA / Clinical Research Associate- FSP

Senior CRA / Clinical Research Associate- FSP

ParexelRemote, Quebec, Canada
Télétravail
Temps plein
When our values align, there's no limit to what we can achieve.Parexel FSP is looking for a CRA in the Quebec Area of Canada. Cell Therapy Trial experience strongly preferred.Quebec CRA needs to be ...Voir plusDernière mise à jour : il y a 3 jours
Research Advisor

Research Advisor

Cuso InternationalSherbrooke, QC, CA
This Volunteer Placement is Located in : .Please submit a Spanish Resume and Statement of Interest.Eligibility : Open to Canadian Citizens and Permanent Residents of Canada only.This is your opportuni...Voir plusDernière mise à jour : il y a plus de 30 jours
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Senior Clinical Data Manager

Senior Clinical Data Manager

Saint Laurent Consultingsherbrooke, qc, Canada
Temps plein
On behalf of our client, Saint Laurent Consulting is hiring a Senior Clinical Data Manager.This role involves leading clinical data management activities for various projects, ensuring data integri...Voir plusDernière mise à jour : il y a 10 heures
Specialist I, Clinical Solutions - SCI

Specialist I, Clinical Solutions - SCI

SysmexQC, CA
70 200,00 $CA par an
This is the time to let your talent come to life.To maximize your knowledge and use it for the greater good.To work with the best professionals using state-of-the-art technology, and improve lives ...Voir plusDernière mise à jour : il y a plus de 30 jours
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Oncology Clinical Research Associate II - WEST CANADA (no travel)

Oncology Clinical Research Associate II - WEST CANADA (no travel)

ICON Strategic Solutionssherbrooke, qc, Canada
Temps plein
As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Works on multiple trials within Onco...Voir plusDernière mise à jour : il y a 10 heures
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Clinical Specialist

Clinical Specialist

Medtronicsherbrooke, qc, Canada
Temps plein
At Medtronic, you can begin a lifelong career focused on research and innovation, championing equity and access to healthcare for all. Your leadership will make an impact, removing barriers to drive...Voir plusDernière mise à jour : il y a 10 heures
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Research & Development Technologist

Research & Development Technologist

Yoplait Liberté CanadaGreater Montreal Metropolitan Area, Canada
Temps plein
The Dairy Research and Development Technologist, specializing in yogurt manufacturing, supports new product development activities, pilot tests, and production trials. They work under the supervisio...Voir plusDernière mise à jour : il y a 7 heures
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Clinical Business Analyst

Clinical Business Analyst

Tek Leaders Incsaint-esprit, qc, Canada
Temps plein
Role : Technical Clinical System Analyst – Healthcare (Utilization Management).Type of Hire - Contract / C2H : Contract.We are seeking a Technical Clinical Analyst with expertise in Clinical Utilizati...Voir plusDernière mise à jour : il y a 10 heures
Vendor Manager

Vendor Manager

AlimentivSherbrooke, Quebec, ,
Temps plein
The Vendor Manager (VM) is accountable for the evaluation, integration, oversight, and performance of vendors selected for Alimentiv clinical research and medical imaging services, from vendor iden...Voir plusDernière mise à jour : il y a 9 jours
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Lead Clinical Data Manager

Lead Clinical Data Manager

Warman O'Briensaint-esprit, qc, Canada
Temps plein
Senior Clinical Data Manager | Global CRO | Full Time | Remote North America.Our client is a well-established mid-sized CRO based in the Toronto Area and known for providing top-notch clinical solu...Voir plusDernière mise à jour : il y a 10 heures
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Clinical Database Developer

Clinical Database Developer

Planet Pharmasaint-esprit, qc, Canada
CDI
We are currently partnered with one of our leading global health care clients who are seeking Clinical Database Developer on a remote basis in Canada. Develops programming / configuration of Veeva and...Voir plusDernière mise à jour : il y a 10 heures
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Regulatory Affairs Manager (Part-Time, Canada Based)

Regulatory Affairs Manager (Part-Time, Canada Based)

Advanced Clinicalsaint-esprit, qc, Canada
Temps partiel
Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the ...Voir plusDernière mise à jour : il y a 10 heures
Remote Data Research Intern

Remote Data Research Intern

FocusGroupPanelSaint-Louis-de-Gonzague, Quebec, Canada
Télétravail
Temps plein +1
Remote Work From Home Data Entry Clerk for Entry Level Position.Work at home position for job seekers from virtually any work background who are interested in part-time, side gigs, micro jobs, wo...Voir plusDernière mise à jour : il y a 4 jours
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Manager of Market Research and Commercial Insights

Manager of Market Research and Commercial Insights

Telnasherbrooke, qc, Canada
Temps plein
Telna is seeking an experienced and strategic Director of Market Research and Commercial Insights to lead our market research initiatives and commercial strategy development.In this role, you will ...Voir plusDernière mise à jour : il y a 10 heures
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Vice President, Early-Stage Contract Research Organization (CRO)

Vice President, Early-Stage Contract Research Organization (CRO)

BridgeBright Search and Advisorysaint-esprit, qc, Canada
Temps plein
Vice President, Early-Stage Contract Research Organization (CRO).Organization : Centre for Probe Development and Commercialization (. Position : Vice President, Early-Stage Contract Research Organizat...Voir plusDernière mise à jour : il y a 10 heures
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Head of Finance (Research / Contract)

Head of Finance (Research / Contract)

Ripplingsaint-esprit, qc, Canada
200,00 $CA par jour
Temps plein
This is an open freelance role to share your feedback.We are looking for feedback from Finance Leaders on our product as we expand in Canada. This is a compensated research hourly research role in e...Voir plusDernière mise à jour : il y a 10 heures
Senior Clinical Project Manager.

Senior Clinical Project Manager.

PSIGreater Montreal Area, QUEBEC, CA
38,79 $CA –48,48 $CA par heure
Management of medium-sized (5-15 countries and / or full service) or large (> .Adherence to and promotion of principles of delivery and service in dealing with PSI customers.Project Supervision of sma...Voir plusDernière mise à jour : il y a plus de 30 jours
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RFR-CIS-060 - Clinical Informatics Specialist

RFR-CIS-060 - Clinical Informatics Specialist

Amyanteksaint-esprit, qc, Canada
Temps plein
RFR-CIS-060 - Clinical Informatics Specialist.Services will be performed via remote access.Services shall not be performed remotely from outside of Canada. Degree or Diploma in healthcare informatic...Voir plusDernière mise à jour : il y a 10 heures
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Clinical Research Associate / Project Supervisor (French Speaker)

Clinical Research Associate / Project Supervisor (French Speaker)

Tigermedsherbrooke, qc, Canada
Temps plein
This Positions is a mixed Role of CRA and Project Supervisor.This position is responsible for project management and study site management from site selection to initiation until monitoring and clo...Voir plusDernière mise à jour : il y a 10 heures
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Clinical Data Manager / / (full-time, remote)

Clinical Data Manager / / (full-time, remote)

Everest Clinical Research.sherbrooke, qc, Canada
Télétravail
Temps plein
Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device...Voir plusDernière mise à jour : il y a 10 heures
Senior CRA / Clinical Research Associate- FSP

Senior CRA / Clinical Research Associate- FSP

ParexelRemote, Quebec, Canada
Il y a 3 jours
Type de contrat
  • Temps plein
  • Télétravail
Description de poste

When our values align, there's no limit to what we can achieve.

Parexel FSP is looking for a CRA in the Quebec Area of Canada.

Cell Therapy Trial experience strongly preferred.

Quebec CRA needs to be bilingual.

Job Purpose :

The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team / Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.

The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.

Key Accountabilities :

Site Management Responsibilities

  • Contributes to the selection of potential investigators.
  • In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application / documents to EC / IRB and to Regulatory Authorities for start-up and for the duration of the study.
  • Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
  • Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
  • Actively participates in Local Study Team (LST) meetings.
  • Contributes to National Investigators meetings, as applicable.
  • Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality / performance) within the LST.
  • Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
  • Updates CTMS and other systems with data from study sites as per required timelines.
  • Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
  • Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits.
  • Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
  • Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
  • Ensures data query resolution in a timely manner.
  • Works with data management to ensure robust quality of the collected study data.
  • Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
  • Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
  • Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
  • Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and / or Clinical Quality Management (CQM) as required.
  • Assists site in maintaining inspection ready ISF.
  • Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
  • Ensures timely collection / uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports / participates in regular QC checks performed by LSAD or delegate.
  • Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
  • Provides feedback on any research related information including sites / investigators / competing studies that might be useful for the local market.
  • Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager.

Compliance with Sponsor Standards

  • Ensures compliance with the Client’s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).
  • Ensures compliance with local, national, and regional legislation, as applicable.
  • Completes timesheets accurately as required.
  • Compliance with Parexel Standards

  • Complies with required training curriculum.
  • Completes timesheets accurately as required.
  • Submits expense reports as required.
  • Updates CV as required.
  • Maintains working knowledge of and complies with Parexel / Client processes, ICH-GCPs and other applicable requirements.
  • Skills (Essential) :

  • Excellent attention to detail.
  • Good written and verbal communication skills.
  • Good collaboration and interpersonal skills.
  • Good negotiation skills.
  • Proficient in written and spoken English language required.
  • Fluency in local language(s) required.
  • Skills (Desirable) :

  • Ability to work in an environment of remote collaborators.
  • Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
  • Ability to look for and champion more efficient and effective methods / processes of delivering quality clinical trials with reduced budget and in less time.
  • Good analytical and problem-solving skills.
  • Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
  • Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems / software in an e-enabled environment.
  • Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
  • Knowledge and Experience (Essential) :

  • Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP / GDP.
  • Good knowledge of relevant local regulations.
  • Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
  • Basic understanding of the drug development process.
  • Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
  • Knowledge and Experience (Desired) :

  • Familiar with risk-based monitoring approach including remote monitoring.
  • Good cultural awareness.
  • Education :

  • Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
  • Other :

  • Ability to travel nationally / internationally as Required
  • Valid driving license per country requirements, as applicable.