Regulatory Affairs Assistant
6 months ago
The Regulatory Affairs Assistant is responsible for handling regulatory documents and maintaining the Investigator’s Study Files (ISFs) for all studies at the clinical research unit.
**RESPONSABILITIES**
More specifically, the Regulatory Affairs Assistant must:
- Track the signatures of regulatory forms (i.e., QIU, FDA1572, financial disclosure forms) and other required documents (i.e., protocol, Investigator’s Brochure) by necessary personnel;
- Prepare and update the various documents necessary for the creation of the files of the persons involved in a research project (e.g., delegation log, CV, attestation of training, etc.);
- Maintain the investigator's study files (ISF) binders up to date;
- Assist the Clinical Research Coordinators and Assistant/Associate Clinical Research Coordinator in communicating with the CRA and performing clerical duties;
- Assist the Clinical Research Coordinators during regulatory inspections and sponsor audits;
- Assist with administrative work and other related tasks required for the Clinical Research Unit.
**Requirements**:
**IDEAL PROFILE**
****
**Education**
- College degree;
- Diploma in Regulatory Affairs is an asset;
**Experience**
- At least 1 year of experience in clinical research or regulatory affairs.
**Knowledge and skills**
- Bilingual French/English (excellent oral and written);
- Excellent knowledge of Word, Excel and PowerPoint;
- Quick learner, detail oriented, organized, good adaptability, and versatile.
Our company:
**The work environment**
At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
**In this position, you will be eligible for the following perks**:
- Permanent full-time position
- Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
- Offices near public transportation (Sherbrooke metro station or Saint-Laurent metro station)
- Ongoing learning and development
**Work Location**
This position is based at our modern and bright clinic in Montreal (3530, Boulevard St-Laurent, H2X 2V1). The workplace is easily accessible by metro (Sherbrooke Station or St-Laurent Station), by bus (several lines) or by car (underground parking available for a daily fee).
**About Innovaderm**
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Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.
**_
Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request._**
**_
Innovaderm only accepts applicants who can legally work in Canada._**
Description - Fr:
L'assistant(e) en affaires réglementaires est chargé(e) de gérer les documents réglementaires et de tenir à jour les dossiers d'étude de l'investigateur ("ISF") pour toutes les études de l'unité de recherche clinique.
**RESPONSABILITÉS**
Plus précisément, l'assistant en affaires réglementaires devra:
- Assurer le suivi des signatures des formulaires réglementaires (i.e. QIU, FDA1572, formulaires de divulgation financière) et des autres documents requis (i.e. protocole, brochure de l'investigateur) par le personnel nécessaire ;
- Préparer et mettre à jour les différents documents nécessaires à la constitution des dossiers des personnes impliquées dans un projet de recherche (par exemple, journal de délégation, CV, attestation de formation, etc ;)
- Maintenir à jour les cartables des dossiers d'étude de l'investigateur (ISF) ;
- Assister les coordonnateurs de recherche clinique et l'assistant/associé coordonnateur de recherche clinique dans la communication avec le CRA et l'exécution de tâches administratives ;
- Assister les coordonnateurs de la recherche clinique lors des inspections réglementaires et des audits
- Assister au travail administratif et aux autres tâches connexes requises pour l'unité de recherche clinique.****
Profil recherché:
**Éducation**
- Diplôme collégial ;
- Un diplôme en affaires réglementaires est un atout****
**Expérience**
- Au moins 1 an d'expérience en recherche clinique ou en affaires réglementaires
**Aptitudes et connaissances**
- Bilingue français/anglais (excellent tant à l'oral qu’à l'écrit)
- Excellente connaissance de Word, Excel et PowerPoint
- Capacité d'apprentissage rapide, souci du détail, sens de l'organisation, bonne capacité d'adaptation et polyvalence
Notre entreprise:
**L’environnement de travai
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