Clinical Research Associate
Il y a 5 mois
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Who is PPD Clinical Research Services?**
PPD is a leading global contract research organization. Our purpose is to improve health. Our mission is to help customers deliver life-changing therapies. Our strategy is to bend the cost and time curve of drug development and optimize value for our customers. PPD is now part of Thermo Fisher Scientific. As the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer. We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicine
**The PPD FSP Solution**:
PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.
Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.
**Clinical Research Associate - Client-dedicated - Belgium**
**Responsibilities include but are not limited to**:
- Monitoring independently different sites, including RBM.
- Participation in investigator meeting as necessary
- Ensuring the trial is conducted in accordance with the approved protocol ICH-GCP guidelines, SOPs etc
- Ensuring effective communication between investigational sites and internal/external stakeholders
- Working on project work and initiatives for process improvement as required
**Requirements**:
- Education and Experience:_
- Degree in **pharmacy, life science or related field**:
- 1 - 3 years’ experience in a pharmaceutical, biotech or CRO company - preferred
- Independent **clinical monitoring experience, at least 1 year**:
- ** Oncology **trials experience - preferred
- Fluency in English, French and Dutch
- Knowledge, Skills and Abilities:_
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- 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
**Physical Requirements / Work Environment**
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, 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. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does 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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