Job Opportunities in Poland
October 1, 2024
Thermo Fisher Scientific
Gdynia
OTHER
Data Compliance Coordinator
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job 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 – To enable 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.
This is a meaningful but truly exciting opportunity to join Synexus as a Data Compliance Coordinator for our dedicated research site in Gdynia, Poland.
Summarized Purpose:
Supports compliance to the clinical trial process. Helps ensure all study documentation and source data is captured accurately in e CRF, up to date and first time right. Assists with quality reviews and answers any e CRF queries for studies with low complexity in a timely manner.
Key roles and responsibilities:
Education and Experience:
Knowledge, Skills and Abilities:
Standard (Mon-Fri)
Environmental Conditions
Office
Job 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 – To enable 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.
Alongside clinical research through our PPD® clinical research portfolio, our work in Accelerated Enrollment Solutions optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future
This is a meaningful but truly exciting opportunity to join Synexus as a Data Compliance Coordinator for our dedicated research site in Gdynia, Poland.
Summarized Purpose:
Supports compliance to the clinical trial process. Helps ensure all study documentation and source data is captured accurately in e CRF, up to date and first time right. Assists with quality reviews and answers any e CRF queries for studies with low complexity in a timely manner.
Key roles and responsibilities:
- 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 e CRF from the source notes and helps track the flow of the e CRFs 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.
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
- Good working knowledge of Business English
- Basic MS Office and computer skills
- Ability to learn basic medical terminology
- Good attention to detail
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