Clinical Research Associate
3 weeks ago
Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- 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 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.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
**Qualifications**:
- Bachelor's Degree in scientific discipline or health care required
- Requires at least 2 years of year of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good 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.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at
-
Associate Clinical Research Associate
2 weeks ago
Kirkland, Canada Merck Sharp & Dohme Full time**Associate Clinical Research Associate (West)** **Location**:We are currently recruiting two positions in the Western Canada - 1 in Vancouver & 1 in Winnipeg Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy...
-
Clinical Research Associate Manager
3 weeks ago
Kirkland, Canada Merck Sharp & Dohme Full time**Clinical Research Associate Manager** **Location: Based in British Columbia or Alberta** This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Clinical Research Director or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 Clinical Research Associates and to ensure...
-
Clinical Research Associate 1, Canada
2 weeks ago
Kirkland, Canada Novasyte Full timeApplicants must be located in Eastern Canada. PURPOSE / BASIC FUNCTIONS: - Engages in company training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practices, and applicable regulatory requirements. Will engage in extensive...
-
Clinical Research Associate
4 days ago
Kirkland, Canada Novasyte Full timeWhether you’re beginning or continuing your career as a CRA, this role is an ideal stepping-stone. You’ll have training and development to plan and progress your career in the direction you choose. And you won’t do it alone - you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards. - Award...
-
Contract Clinical Research Associate, Oncology
4 weeks ago
Kirkland, Canada Novasyte Full timeIQVIA Biotech is seeking a part-time Contract Sr. CRA with Oncology monitoring experience. Must be based in Eastern Canada. IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest...
-
Clinical Trials Assistant
2 weeks ago
Kirkland, Canada IQVIA Full timeJob Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...
-
Chef, Recherche Clinique
1 week ago
Kirkland, Canada Merck Sharp & Dohme Full time**Chef, Recherche clinique** (2 postes) Ce rôle est principalement responsable de la gestion de bout en bout du rendement et des projets pour les protocoles attribués dans un pays, conformément aux Bonnes pratiques cliniques de la Conférence internationale sur l’harmonisation, aux règlements du pays, aux politiques et procédures de notre...
-
Associé de recherche clinique, – francophone
7 days ago
Kirkland, Canada IQVIA Full timeJob Description · 3 years of experience in follow-up; · BASIC FUNCTIONS: Participates in the preparation and execution of Phase I to IV clinical trials. Oversees the progress of clinical investigations by conducting interim site assessment, initiation, and closure visits. Monitors clinical trials in accordance with clinical best practices and...
-
Chef, Recherche Clinique
3 weeks ago
Kirkland, Canada Merck Sharp & Dohme Full time**Chef, Recherche clinique** Ce rôle est principalement responsable de la gestion de bout en bout du rendement et des projets pour les protocoles attribués dans un pays, conformément aux Bonnes pratiques cliniques de la Conférence internationale sur l’harmonisation, aux règlements du pays, aux politiques et procédures de notre entreprise, aux normes...
-
Clinical Research Associate
4 weeks ago
Kirkland, Canada Merck Canada inc Full timeJob Description Notre équipe de recherche clinique et de pharmacovigilance repousse les limites de la santé mondiale grâce à la recherche et à l’innovation. Grâce aux essais cliniques et à la surveillance, nous garantissons la sécurité et l’efficacité de nos produits existants et en cours de développement pour produire des médicaments sûrs,...
-
Clinical Research Associate
4 weeks ago
Kirkland, Canada Merck Canada inc Full timeJob Description Notre équipe de recherche clinique et de pharmacovigilance repousse les limites de la santé mondiale grâce à la recherche et à l’innovation. Grâce aux essais cliniques et à la surveillance, nous garantissons la sécurité et l’efficacité de nos produits existants et en cours de développement pour produire des médicaments sûrs,...
-
Clinical Product Management Lead
24 hours ago
Kirkland, Quebec, Canada IQVIA Argentina Full timeJob DescriptionThe Associate Director, COA Management will play a critical role in driving the success of our Patient-Centered Solutions team. This individual will be responsible for developing and executing strategies to grow our COA portfolio, while ensuring the highest level of quality and integrity in our products. The ideal candidate will have a strong...
-
Senior Clinical Operations Director
24 hours ago
Kirkland, Quebec, Canada IQVIA Argentina Full timeCompany OverviewIQVIA Argentina is a leading provider of scientific solutions for the pharmaceutical and medical device industries. We help our clients navigate the complexities of clinical trials, real-world evidence, and consulting to bring innovative treatments to market.About the RoleWe are seeking an experienced Associate Director, COA Management to...
-
Kirkland, Canada IQVIA Argentina Full timeAssociate Director, COA Management - Patient Centered Solutions Overview IQVIA provides scientific solutions spanning clinical trials, real world evidence, and consulting in all areas of the drug product lifecycle. The Patient Centered Solutions (PCS) team leads the industry in generating data to ensure that the patient voice is incorporated into the...
-
Associate Laboratory Project Services Manager
2 weeks ago
Kirkland, Canada Novasyte Full timeWe are seeking Associate Laboratory Project Manager to join Q2 Solutions, IQVIA’s laboratory business Remote. We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development. As an Associate...
-
17732-assoc Clin Project Mgr
3 weeks ago
Kirkland, Canada IQVIA Full time**Job Overview** Associate Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Associate Project Lead is a member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with...
-
Clinical Research Manager
6 days ago
Kirkland, Canada Merck Canada inc Full timeJob Description Chef, Recherche clinique (2 postes) Ce rôle est principalement responsable de la gestion de bout en bout du rendement et des projets pour les protocoles attribués dans un pays, conformément aux Bonnes pratiques cliniques de la Conférence internationale sur l'harmonisation, aux règlements du pays, aux politiques et procédures de notre...
-
Clinical Research Manager
6 days ago
Kirkland, Canada Merck Canada inc Full timeJob Description Chef, Recherche clinique Ce rôle est principalement responsable de la gestion de bout en bout du rendement et des projets pour les protocoles attribués dans un pays, conformément aux Bonnes pratiques cliniques de la Conférence internationale sur l'harmonisation, aux règlements du pays, aux politiques et procédures de notre entreprise,...
-
Kirkland, Canada Healing Tree Psychology and Wellness Centre Full timeOur practice is expanding very rapidly and we are looking for someone who wishes to grow with us. The Healing Tree Psychology and Wellness Centre’s vision is to become the West Island’s premier holistic psychology clinic providing a whole-person approach to healing and recovery from a variety of emotional and psychological disorders. We strive to become...
-
Kirkland, Canada Healing Tree Psychology and Wellness Centre Full timeOur practice is expanding very rapidly and we are looking for someone who wishes to grow with us. The Healing Tree Psychology and Wellness Centre’s vision is to become the West Island’s premier holistic psychology clinic providing a whole-person approach to healing and recovery from a variety of emotional and psychological disorders. We strive to become...
