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Clinical Research Associate
3 semanas atrás
Overview:
TFS HealthScience is excited to be expanding our Site Management team and we are looking for an experienced, highly motivated Clinical Research Associate (CRA) who shares our vision of providing clinical research excellence. Our Site Management team is a highly experienced international group of professionals led by an industry expert.
We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.
Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. Together we make a difference.
The Clinical Research Associate (CRA) is part of Clinical Operations or Strategic Resourcing Solutions Unit and is responsible for the initiation, on-site and remote monitoring and termination of investigative sites during study conduct, according to company policies, SOPs and regulatory requirements.
**Responsibilities**:
- Review Informed Consent documents for essential elements and protocol specifics
- Update CTMS system with site and study information
- Identify site problems/deficiencies and bring to the attention of management through trip reporting, memos and verbal communication with Project Manager or Lead CRA.
- Initiates corrective action to resolve issues as directed by supervisor.
Qualifications:
- Bachelor’s Degree, preferably in life science or nursing; or equivalent
- Minimum 3 years of relevant clinical experience, Oncology are experience preferable
- Able to work in a fast paced environment with changing priorities
- Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas
- Possess the understanding of Good Clinical Practice regulations, ICH guidelines
- Experience in Risk Based Monitoring
- Ability to work independently as well as in a team matrix organization
- Excellent written and verbal communication skills.
- French speaking and Fluent English
- Excellent organizational skills
- Ability and willingness to travel up to 60-70%
- TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the _
- privacy notice_
- for further details._
- TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits._
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