Clinical Research Associate
il y a 4 semaines
Job Summary
We are seeking a highly skilled Clinical Research Associate to join our team at Thermo Fisher Scientific. As a Clinical Research Associate, you will be responsible for monitoring and managing clinical trials, ensuring compliance with regulatory requirements and company policies.
Key Responsibilities
- Monitor and manage clinical trials, including site initiation, interim visits, and close-out visits
- Ensure compliance with regulatory requirements, including ICH-GCP guidelines and SOPs
- Develop and maintain effective communication with investigational sites and internal/external stakeholders
- Participate in investigator meetings and ensure trial conduct in accordance with approved protocol
- Work on project work and initiatives for process improvement as required
Requirements
- Education: Degree in pharmacy, life science, or related field
- Experience: 0-1 years' clinical monitoring experience
- Language: Fluency in English and French
- Location: Ability to work a combination of office- and home-based in the Paris area
Knowledge, Skills and Abilities
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Excellent understanding and demonstrated application of GCPs and applicable SOPs
- Management of regulatory and/or IEC questions
- Development and preparation of the local informed consent form
- Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
- Management of the delivery of study supplies
- Strong customer focus
- Effective interpersonal skills
- Strong attention to detail
- Effective organizational and time management skills
- Proven flexibility and adaptability
- Ability to work in a team or independently as required
- Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
- Good presentation skills
About Us
At Thermo Fisher Scientific, we are committed to enabling our customers to make the world healthier, cleaner, and safer. We share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.
We are an EEO/Affirmative Action Employer and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
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