Job Description

Bilingual Senior Clinical Research Associate, Dermatology

The bilingual Senior Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

Please note that offers are subject to the outcome of Background verifications

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This role will be perfect for you if:

• You are a Senior CRA with a demonstrated ability to work autonomously to meet quality standards and deadlines
• Focusing on dermatology and developing an expertise in this therapeutic area is interesting to you
• You enjoy working for a mid-sized CRO where your contributions are noticed and valued

RESPONSIBILITIES

The Senior clinical research associate (CRA) :

• Conducts site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Innovaderm and sponsor SOPs, ICH/CGP guidelines and applicable regulations
• Participates in investigators\xe2\x80\x99 meetings
• Prepares site visit reports and follow-up letters to the investigator
• Builds productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets
• Performs source data verification, ensures on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequate
• Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training

Our company:

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.

As a Senior Clinical Research Associate, you will be eligible for the following perks:

• Flexible work schedule
• Permanent full-time position
• Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
• Ongoing learning and development

• This position is home-based with local or regional travel required to clinical research sites
• The employee is expected to maintain a suitable dedicated home office or work space and be located near a major travel hub
• A thorough background check is to be performed prior hiring

About Innovaderm

Innovaderm is a contract research organization (CRO) specialized in dermatology with a team of over 175 employees. 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.

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.

We thank you for your application and please note that only those selected for an interview will be contacted.

Innovaderm only accepts applicants with a work permit for Canada.

Description - Fr:

Associ\xc3\xa9 de recherche clinique Senior, bilingue, Dermatologie

L\'associ\xc3\xa9 de recherche clinique Senior, bilingue, surveillera la progression des \xc3\xa9tudes cliniques sur les sites d\'investigation ou \xc3\xa0 distance, et s\'assurera que les essais cliniques sont men\xc3\xa9s, enregistr\xc3\xa9s et rapport\xc3\xa9s conform\xc3\xa9ment au protocole, aux proc\xc3\xa9dures op\xc3\xa9ratoires normalis\xc3\xa9es, aux ICH-GCP et \xc3\xa0 toutes les exigences r\xc3\xa9glementaires applicables.

Ce poste sera parfait pour vous si :

• Vous \xc3\xaates un associ\xc3\xa9 de recherche clinique exp\xc3\xa9riment\xc3\xa9 avec une capacit\xc3\xa9 d\xc3\xa9montr\xc3\xa9e \xc3\xa0 travailler de mani\xc3\xa8re autonome pour respecter les normes de qualit\xc3\xa9 et les d\xc3\xa9lais.
• Vous \xc3\xaates int\xc3\xa9ress\xc3\xa9 par le fait de vous concentrer sur la dermatologie et de d\xc3\xa9velopper une expertise dans ce domaine th\xc3\xa9rapeutique.
• Vous aimez travailler pour un CRO de taille moyenne o\xc3\xb9 vos contributions sont remarqu\xc3\xa9es et valoris\xc3\xa9es.

RESPONSABILIT\xc3\x89S

L\'associ\xc3\xa9 de recherche clinique Senior :

• Effectue les visites de qualification, d\'initiation, de surveillance et de cl\xc3\xb4ture des sites de recherche conform\xc3\xa9ment au plan de surveillance, aux proc\xc3\xa9dures op\xc3\xa9ratoires normalis\xc3\xa9es d\'Innovaderm et du promoteur, aux directives ICH/CGP et aux r\xc3\xa9glementations applicables.
• Participer aux r\xc3\xa9unions des investigateurs
• Pr\xc3\xa9pare les rapports de visite des sites et les lettres de suivi destin\xc3\xa9es \xc3\xa0 l\'investigateur.
• \xc3\x89tabli des relations productives avec les investigateurs et le personnel du site pour atteindre les objectifs de l\'\xc3\xa9tude, y compris les objectifs de recrutement des patients.
• Effectue la v\xc3\xa9rification des donn\xc3\xa9es sources, s\'assure que le stockage, la distribution et la comptabilit\xc3\xa9 des m\xc3\xa9dicaments de l\'\xc3\xa9tude sur le site, la collecte des donn\xc3\xa9es et la collecte des documents r\xc3\xa9glementaires sont ad\xc3\xa9quats.

Profil recherch\xc3\xa9:

\xc3\x89ducation

• B.Sc. dans un domaine pertinent pour la recherche clinique, dipl\xc3\xb4me d\'infirmier et/ou exp\xc3\xa9rience \xc3\xa9quivalente

Exp\xc3\xa9rience

• 5 ans d\'exp\xc3\xa9rience dans la conduite de la surveillance clinique sur site dans l\'industrie biotechnologique, pharmaceutique et/ou des organismes de recherche sous contrat (CRO).

Connaissances et comp\xc3\xa9tences

• Bonne connaissance des normes ICH/GCP et des exigences r\xc3\xa9glementaires applicables.
• Solides comp\xc3\xa9tences en communication orale et \xc3\xa9crite en anglais
• Capacit\xc3\xa9 \xc3\xa0 hi\xc3\xa9rarchiser les diff\xc3\xa9rentes missions et \xc3\xa0 travailler sous pression tout en portant une attention particuli\xc3\xa8re aux d\xc3\xa9tails et en respectant les d\xc3\xa9lais.
• Excellentes capacit\xc3\xa9s de jugement et de r\xc3\xa9solution de probl\xc3\xa8mes
• D\xc3\xa9placement sur les sites de recherche environ 65% du temps
• Excellente connaissance de Microsoft Office (i.e., Word, Excel, PowerPoint)
• Exp\xc3\xa9rience en dermatologie, fort atout

Notre entreprise:

L\xe2\x80\x99environnement de travail

Chez Innovaderm, vous travaillerez avec des collaborateurs comp\xc3\xa9tents et dynamiques. Nos valeurs sont la collaboration, l\xe2\x80\x99innovation, la fiabilit\xc3\xa9 et la r\xc3\xa9activit\xc3\xa9. Nous offrons un environnement de travail stimulant et des possibilit\xc3\xa9s d\xe2\x80\x99avancement int\xc3\xa9ressantes.

Dans le poste, vous b\xc3\xa9n\xc3\xa9ficierez des conditions suivantes :

• Ce poste est \xc3\xa0 domicile avec des d\xc3\xa9placements locaux ou r\xc3\xa9gionaux requis vers des sites de recherche clinique
• On s\'attend \xc3\xa0 ce que l\'employ\xc3\xa9 maintienne un bureau \xc3\xa0 domicile ou un espace de travail d\xc3\xa9di\xc3\xa9 appropri\xc3\xa9 et soit situ\xc3\xa9 \xc3\xa0 proximit\xc3\xa9 d\'un important centre de voyage (Montr\xc3\xa9al)
• Gamme d\xe2\x80\x99avantages sociaux (assurances m\xc3\xa9dicales, dentaire, vision, r\xc3\xa9gime de retraite, vacances, journ\xc3\xa9es personnelles, clinique m\xc3\xa9dicale virtuelle, rabais sur le transport en commun, activit\xc3\xa9s sociales)
• Bureau \xc3\xa0 proximit\xc3\xa9 du transport en commun (m\xc3\xa9tro Saint-Laurent ou m\xc3\xa9tro Sherbrooke)
• Formation continue et d\xc3\xa9veloppement

\xc3\x80 propos d\xe2\x80\x99Innovaderm

Innovaderm est une entreprise de recherche clinique contractuelle (CRO) sp\xc3\xa9cialis\xc3\xa9e en dermatologie. Depuis ses d\xc3\xa9buts en 2000, notre entreprise \xc3\xa0 taille humaine b\xc3\xa9n\xc3\xa9ficie d\xe2\x80\x99une solide r\xc3\xa9putation autant pour la qualit\xc3\xa9 de la recherche effectu\xc3\xa9e que pour la qualit\xc3\xa9 des soins offerts, d\xc3\xa9passant les attentes de ses clients. Bas\xc3\xa9 \xc3\xa0 Montr\xc3\xa9al, Innovaderm continue aujourd\xe2\x80\x99hui sa croissance en Am\xc3\xa9rique du Nord et en Europe.

Innovaderm s\xe2\x80\x99engage \xc3\xa0 assurer une approche \xc3\xa9quitable ainsi que des opportunit\xc3\xa9s \xc3\xa9quivalentes pour tous les candidats. \xc3\x80 ce titre, Innovaderm fournira sur demande des accommodations aux candidats ayant un handicap, et ce, \xc3\xa0 travers toutes les \xc3\xa9tapes du processus de recrutement, si demand\xc3\xa9.

Innovaderm accepte uniquement les candidats pouvant l\xc3\xa9galement travailler au Canada.

\xef\xbb\xbfLe genre masculin est utilis\xc3\xa9 sans discrimination et dans le seul but d\'all\xc3\xa9ger le texte.

Education

• B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience

Experience

• 5 years experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry

Knowledge and skills

• Good knowledge of ICH/GCP standards and applicable regulatory requirements
• Strong verbal and written communication skills in French and in English
• Ability to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelines
• Excellent judgement and problem-solving skills
• Travel to research sites approximately 65% of the time
• Excellent knowledge of Microsoft Office (i.e., Word, Excel, PowerPoint)
• Experience in dermatology is an asset

Innovaderm Research