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Clinical Research Associate
Il y a 2 mois
Pivotal is a leading full-service contract research organization in Europe, renowned for its commitment to clinical research excellence. Our team is passionate about making a positive impact through medical science and technology.
Job SummaryWe are seeking an experienced Clinical Research Associate to join our team. As a CRA/SCRA, you will be part of multi-national project teams, delivering exceptional customer service on challenging studies. Your responsibilities will include site selection, initiation, monitoring, and close-out visits, as well as collaborating with the Regulatory team to obtain approvals.
Key Responsibilities- Perform site selection, initiation, monitoring, and close-out visits to ensure high-quality data collection.
- Collaborate with the Regulatory team to obtain Ethic Committees (ECs) and Health Authorities (HAs) approvals in accordance with national/international regulations.
- Evaluate the quality and integrity of site practices, using judgment and experience to evaluate overall performance and provide recommendations.
- Manage site progress by tracking recruitment, eCRF completion, and data query resolution.
- Participate in problem-solving and risk-mitigation strategies, collaborating with experts at study sites and client representatives.
- Maintain a working knowledge of relevant regulations and company SOPs/processes.
- Demonstrate diligence in protecting the confidentiality of each subject/patient.
- University Degree in life science or other scientific discipline or apprenticeship in health care.
- Minimum of two years of on-site monitoring experience, alternatively an equivalent combination of education, training, and experience.
- Knowledge of applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Flexibility to travel 6-8 visits per month.
- Strong written and verbal communication skills, attention to detail, and ability to work in a fast-paced environment.
- Ability to work autonomously.
- Fluency in English and French.
- Good knowledge of Office (Word, Excel, and PowerPoint).
- Resources that promote career growth.
- Leaders that support flexible work schedules.
- Trainings to help build therapeutic knowledge.
- Dynamic work environments that expose you to new experiences.
