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Data Compliance Coordinator
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Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
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.
Location/Division Specific Information
Our Early Development team focuses on Phase I and IB trials which represent the first practical tests of a compound’s clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover, they set the stage for subsequent studies that will ultimately determine your compound’s efficacy, safety and positive impact on patient’s lives.
Do you have a data entry/quality compliance background?
Interested in the dynamic clinical research industry?
We are currently looking to recruit a Data Compliance Coordinator for our clinical site in Prague, Czech Republic.
Key responsibilities for a Data Compliance Coordinator are as follows:
- Maintains ISF and study trackers as delegated and supports the verification that ICFs are correctly completed.
- Assists with data capturing activities on one or more studies. May provide support across multiple sites and/or regions.
- Ensures accurate and timely entry of all data in the eCRF from the source notes and helps track the flow of the eCRFs and queries.
- Assists with the verification that protocol visit windows are correct according to the protocol requirements and reports deviations.
- May assist monitors and sponsor representatives with query resolutions after monitoring visits. Escalates to management as needed.
- Learns and adheres to company SOP and COP and assists with input during the review process.
- Adheres to the rules and regulations of ICH, GCP and other regulatory and ethical guidelines and data protection regulations.
- Assists with drafting compliance reports.
Qualifications:
Education and Experience:
- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Technical positions may require a certificate
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
Knowledge, Skills and Abilities:
- Ability to multi-task and support multiples studies with a number of participants simultaneously
- Good interpersonal skills
- Excellent communication skills with Czech and English
- Basic MS Office and computer skills
- Ability to learn basic medical terminology
- Good attention to detail
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Nos aseguraremos de que las personas con discapacidades reciban adaptaciones razonables para participar en el proceso de solicitud de empleo o entrevista de trabajo, para que puedan ejercer las funciones de trabajo esenciales y recibir otros beneficios y privilegios del empleo. Comuníquese con nosotros para solicitar una adaptación.