6 meilleures offres (clinical research associate, manitoba) (à pourvoir)

Clinical Research Associate - Contract
Clinical Development Solutions —Winnipeg, MB
- Contrat
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il y a 4 jours
Project Manager CLL Unit - Level 8 (EMAPS)
University of Manitoba —Winnipeg, MB
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Clinical Research Associate - Contract

Clinical Development Solutions
Winnipeg, MB

Postuler rapidement

Détails du poste

Contrat
Il y a 4 jours

Compétences

Audit de la qualité des données
Utilisation d'un ordinateur
Microsoft Excel
Microsoft Outlook
Recherche clinique
Tenue des dossiers
Baccalauréat
Gestion des données
Préparation de rapports et de présentations
Contrôle de la qualité
Rédaction de rapports
Recrutement
Essais cliniques
Validation des données
Rapport de situation
Procédures opératoires normalisées (PON)
Compétences en communication
Suivi de l'avancement des projets

Description complète du poste

Job Summary:

CDS is looking for a local (Winnipeg Based) Clinical Research Associate (CRA) to perform the clinical monitoring aspects for specific projects on a contract basis.

The responsibility of a Clinical Research Associate (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOPs. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing selection, initiation, periodic monitoring and close-out of investigational sites in accordance with ICH GCP guidelines.

Duties and Responsibilities:

May conduct pre-study site assessment/qualification visits, collection and review essential documents, prepare evaluative reports; participate in the final selection of investigators and study sites and participate in study start-up activities.
May conduct site initiation visits; advise and train site personnel on sponsor and regulatory requirements for study; participate in site meetings and multi-centre investigator meetings and prepare visit reports.
Site Management Activities, including maintain all essential clinical documents and manage supply of investigational product throughout the trials
Conduct site monitoring visits and follow-up on any outstanding issues; ensure all clinical aspects of the studies are being carried out in accordance with the clinical protocol, ICH GCP, state/provincial and federal/country regulations, guidelines and policies; and prepare site status reports and monitoring visit reports.
Review site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identify deficiencies and discrepancies; and provide remedial training and/or initiate corrective action as required.
May conduct investigator site close-out visits and assist in the termination of clinical studies by identifying items and issues for review and/or follow-up; collection of necessary documents, reconciliation of study drug/device and disposition, review of completeness and accuracy of files, retrieval of relevant codes, prepare study close-out / termination reports.
Assist in the reconciliation of and follow up on adverse event reporting, and serious adverse event reporting to ensure appropriate notification and compliance with regulatory agency, IRB/REB and SOPs
May assist sites with preparation for regulatory agency, sponsor, or IRB/REB audits.
Current projects are local (Winnipeg). Future projects may involve travel within Canada & USA up to 60%.
May perform other miscellaneous job-related duties as assigned.

Interacts with (where applicable):

Sponsor personnel. This may include Lead CRA, Project Management, Documentation Personnel, Trial Assistants, Data Management & Clinical Safety.
Internal Quality Assurance.
Associated or trial related Contract Research Organizations (CROs).
Internal Lead CRA, Project Management, Documentation Personnel, Trial Assistants, & Clinical Safety.
Investigational Site Personnel (Principal Investigator, Research Coordinator, etc.).
Clinical Team (other monitors, etc).

Competencies:

Must possess excellent written and verbal communication skills and have the ability to develop and deliver both oral and written presentations.
Ability to make evaluative judgments.
Ability to provide advice, guidance, and support to professional staff in area of specialty
Ability to develop and implement clinical research monitoring plans and standard operating procedures.
Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment.

Qualifications:

Bachelor's degree in life sciences or related field or certification in a related allied health profession from an appropriately accredited institution (i.e. BN, RN, MT, PA, RPh, RT) GCP Certification, or certification with SoCRA or ACRP preferred.
A minimum of 2 years experience in clinical research or related research field preferred.
Knowledge of all regulations and guidelines pertaining to the conduct of clinical trials on human subjects (i.e. ICH GCP, FDA and Health Canada regulations).
Knowledge of randomized controlled clinical trials principles, methodology, and procedures.
Knowledge of current and developing trends and standards in clinical trials monitoring.
Computer/Laptop usage skills (knowledge of Microsoft Office, including Word, PowerPoint, Excel and Outlook).

Accountability:

Ensures compliance with all regulatory and contractual requirements by quality controlling the execution of clinical protocol and data management for a clinical trial(s) at multiple sites.
Ensures validity of studies by establishing and maintaining sound clinical and data collection practices.
Ensures compliance with established protocols, regulatory and contractual requirements; appropriate research methodology; and study timelines by monitoring the conduct and progress of the studies.
Ensures appropriate transmission of clinical case data to the data management centre(s); reviews case report queries and problems, and assists in data review and correction as appropriate.

Application question(s):

This position does not require you to come in to the office located in Winnipeg, MB. However you must live close to the office. Do you live in or around Winnipeg, MB?

Work Location: Remote

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clinical research associate emplois - manitoba

Clinical Research Associate - Contract

Project Manager CLL Unit - Level 8 (EMAPS)

CANADA RESEARCH CHAIR TIER 1

Chef de projet associé, Mesure (Measurement Associate Project Manager), IQVIA Digital

Tier 2 Canada Research Chair - Immunology

Assistant, Associate, or Professor - Internal Medicine

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