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Publié il y a 6 jours

Contract Clinical Research Associate

@ PSI CRO

Calgary, Alberta

TélétravailContrat5+ ans d’expérience
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PSI CRO is hiring a contract Clinical Research Associate to monitor clinical studies at sites across therapeutic areas. The role involves frequent on-site visits, with up to 75% travel, and requires oncology and gastroenterology (IBD) monitoring experience.

Responsabilités :

  • Monitor clinical trial sites on-site across phases I-III
  • Perform source data verification and manage queries
  • Handle investigational product accountability and TMF reconciliation
  • Conduct site initiation, routine monitoring and close-out visits
  • Train site investigators and support regulatory submissions

Résumé des exigences :

  • Life sciences degree or equivalent experience
  • 5+ years independent on-site monitoring
  • Independent oncology trial monitoring experience
  • Independent IBD (gastroenterology) trial monitoring experience
  • Located on Canada's West Coast
  • Ability to travel up to 75%

Outils et compétences

Source et dates

Site carrière / système de candidatures · smartrecruiters

Date publiée par l’employeur
2026-11-04
Première détection par notre source
2026-11-04
Mise à jour du dossier source
2026-11-04

Ces dates décrivent le dossier source, pas une vérification en direct du recrutement. Consultez l’offre originale.

Détails du poste

NiveauIntermédiaire
DomaineProfessions paramédicales
Expérience5 an(s) et plus
Déplacementsavion : modérés · route : modérés
Milieu de travailChez les clients, Bureau
PositionAssis et debout
Exigences physiquesphysique faible · ordinateur élevé
LanguesEnglish
Permis de conduireexigé
FormationBaccalauréat (exigé)
Domaines d’étudesLife Sciences

Résumé et détails rédigés par l’IA à partir de l’offre; l’offre de l’employeur fait foi.

PSI CRO

Profil d’entreprise sauvegardé

Renseignements historiques provenant d’un profil The Jobs API sauvegardé (champs LinkedIn/Crunchbase). Ils ne sont pas vérifiés en temps réel; les chiffres peuvent avoir changé. Les valeurs manquantes restent inconnues.

Description complète de l’entreprise

PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense'​ CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com

Abonnés LinkedIn
329 384
Personnes associées sur LinkedIn
2 861
Bureaux déclarés
  • Baarerstrasse 113a, Zug, 6300, CH
Catégories d’activité
  • Business Information Systems
  • Health Care
  • Pharmaceutical
Autres noms enregistrés
  • PSI CRO
Spécialités
  • Number One Patient Enrollment CRO
  • Clinical Research
  • Clinical Trials
  • Oncology
  • Hematology
  • Multiple Sclerosis
  • Infectious Diseases
  • Patient Enrollment
  • Phase 2
  • Phase 3
  • Pivotal Trials
  • Global Clinical Trials
  • Full-Service Clinical Trials
  • and Radiopharmaceuticals
Le profil indique une agence de recrutement
Non
Investissement total déclaré
0

La devise et la date d’observation ne sont pas fournies; ce n’est ni une valorisation actuelle ni une ronde de financement.

PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s…

ChampValeur
SecteurPharmaceutical Manufacturing
Taille1,001-5,000 employees
Siège socialZug
Type d’organisationPrivately Held
SpécialitésNumber One Patient Enrollment CROClinical ResearchClinical TrialsOncologyHematologyMultiple SclerosisInfectious DiseasesPatient EnrollmentPhase 2 Phase 3
Offres sur Jobsy6
LinkedInVoir la page
Description

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together close to 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.

You will:

  • Act as the main line of communication between the project team, sponsor, and the site
  • Build and maintain a good relationship with the site staff involved in the study conduct
  • Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits
  • Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level
  • Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations
  • Perform source data verification and follows up on data queries at site level; review and manage study risks on a site level
  • Ensure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sites
  • Review essential study documents and reconcile study Investigator Site File (ISF) / TMF at site level
  • Ensures quality (data integrity and compliance) at site level
  • Conduct site audit preparation visits and resolve site audit findings
  • Participate in study site audits and client onsite visits, as required
  • Ensure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ Warehouse
  • Conduct project-specific training of site investigators
  • Support preparation of Investigator newsletters
  • Assist Site Management Associates in maintaining study-specific and corporate tracking systems at site level
  • Support preparation of draft regulatory and ethics committee submission packages
  • Support collection of IP-RED packages at site/country level
  • Facilitate review and reconciliation of the study TMF on country and site levels

Qualifications

  • College/University degree in Life Sciences or an equivalent combination of education, training & experience
  • Located in Canada (West Coast)
  • 5+ years of independent on-site monitoring experience
  • Experience in all types of monitoring visits, in phases I-III
  • Experience independently monitoring Oncology clinical trials required
  • Experience independently monitoring Gastroenterology (IBD) clinical trials required
  • Proficiency in MS Office applications
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills
  • Ability to travel up to 75%
  • Valid driver’s license

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