Clinical Research Associate | Associé de recherche clinique

Clinical Research Associate 35Pharma is a clinical-stage biopharmaceutical company that designs and develops innovative therapeutics for life threatening lung diseases, and musculoskeletal and metabolic disorders. We believe in connecting rigorous science with our innate sense of urgency to rapidly generate breakthrough therapies for patients in need to better quality of life. Our highly qualified team of drug developers and company builders has a track record of advancing complex biologics from discovery through clinical trials. Our R&D facilities are located in the heart of Montréal, Canada, and comprise laboratory space for pre-clinical research as well as manufacturing development that bolster our mission to serve patients in need.Role:The Clinical Research Associate will be responsible for clinical monitoring activities at clinical sites to ensure compliance with the clinical protocol and study procedures, as well as all applicable regulations, guidelines, quality industry standards, internal standard operating procedures (SOPs) and policies. The Clinical Research Associate will be responsible to conduct on-site and remote monitoring visits, to review and collect sites essential documents required for the trial master file (TMF), and be the primary point of contact with sites for the protocol, recruitment status, and essential documents collection.Key Responsibilities:Acts as primary point of contact for clinical sites for the conduct of the protocol.Supports the clinical sites with their patient recruitment initiatives and site-specific recruitment plans.Conducts on-site and remote monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, and site close-out visit).Prepares confirmation and follow-up letters to the investigators and monitoring visit reports.Participates in the preparation and review of study documents such as clinical protocol, informed consent form, laboratory manual, pharmacy manual, recruitment plan, etc.Participates in the planning and conduct of investigator's meeting.Ensures review, collection, and tracking of sites essential documents as well as reconciliation with the TMF.Conducts co-monitoring visits with contract research organizations (CRO) or independent clinical research associates, as necessary.Supports the clinical sites during regulatory inspections and audits.Participates in the development of clinical monitoring SOPs, tools, and templates.May contribute to additional clinical operations activities as deemed necessary to ensure the clinical program success.Qualifications:Bachelor's degree in health sciences, nursing degree, or equivalent experience.Minimum of 2 years' experience in a pharmaceutical or biotechnology company or CRO, in a clinical research associate role conducting on-site monitoring visits.Minimum of 5 years experience in a clinical monitoring, clinical trial management, or project management role in phase 1-3 multicenter clinical trials.Excellent interpersonal skills, strong written and verbal communication (French and English), and strong presentation skills necessary to meet the needs of various audiences.Ability to build effective relationships with site personnel, CRO and vendors staff, and colleagues.Superior problem solving, deductive reasoning and decision-making skills.Excellent time management and organizational skills, ability to prioritize tasks and accomplish set goals efficiently.Excellent attention to detail and ability to maintain detailed and accurate records.Ability to work independently.Excellent knowledge and understanding of the regulatory requirements and good clinical practices.Demonstration of the highest ethical standards, active promotion of trust, respect, and integrity.Proficiency in required softwares (Word, Excel, Power Point), clinical trial systems (i.e., EDC, eTMF, IRT, eCOA) and computer skills.Availability to travel frequently to clinical sites in Canada and the United-States.Contact:Please send your CV and cover letter outlining your motivation and relevant experience for the role to careers@35pharma.com, quoting "35Pharma Posting CRA0411" in the subject line - we are looking forward to hearing from you!---------------Associé de recherche clinique35Pharma est une société biopharmaceutique de stade clinique qui conçoit et développe des thérapies innovantes pour les maladies pulmonaires potentiellement mortelles et les troubles musculo-squelettiques et métaboliques. Nous croyons qu'il est important d'associer une science rigoureuse à notre sens inné de l'urgence afin de générer rapidement des thérapies révolutionnaires pour les patients qui en ont besoin et améliorer leur qualité de vie. Notre équipe hautement qualifiée de développeurs de médicaments et de bâtisseurs d'entreprises a fait ses preuves dans l'avancement de produits biologiques complexes, de la découverte aux essais cliniques. Nos installations de recherche et développement sont situées au c