Associé(e) de recherche clinique (ARC) principal(e)/ Senior …, Mississauga

Vue d’ensemble du poste Effectuer des tâches de suivi et de gestion de site pour une variété de protocoles, de sites et de domaines thérapeutiques. Doit être bilingue français et anglais et situé à Montréal.

Responsibilities

Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.

Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.

Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.

Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.

Act as a mentor for clinical staff including conducting co-monitoring and training visits.

Collaborate and liaise with study team members for project execution support as appropriate.

If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.

If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Required Education and Experience

Bachelor's Degree in scientific discipline or health care preferred.

Requires at least 3 years of on-site monitoring experience.

Equivalent combination of education, training and experience may be accepted in lieu of degree.

In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

Strong therapeutic and protocol knowledge as provided in company training.

Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).

Written and verbal communication skills including good command of English language.

Effective time and financial management skills.

Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Salaire La fourchette salariale de base potentielle pour ce poste, annualisée, est de $102,500.00 - $152,500.00. Le salaire de base réel offert peut varier selon plusieurs facteurs, notamment les qualifications liées à l’emploi telles que les connaissances, les compétences, la formation et l’expérience ; l’emplacement ; et/ou l’horaire (temps plein ou temps partiel). Selon le poste offert, des régimes d’incitation, des primes et/ou d’autres formes de rémunération peuvent être proposés, en plus d’une gamme d’avantages sociaux liés à la santé, au bien‑être et/ou d’autres bénéfices.

Equal Employment Opportunity Statement IQVIA est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale,le handicap, l’âge, l’état matrimonial ou tout autre statut protégé par la loi applicable. Des mesures d’adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement.

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