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 are currently looking to recruit a Data Compliance Coordinator for our clinical site in Hexham, United Kingdom.
This role will be responsible for oversight of data and quality control in the clinical trial process by ensuring all study documentation and source data is accurate and up to date.
Key responsibilities for a Data Compliance Coordinator are as follows:
* Coordinates operational compliance activities on one or more studies to ensure successful delivery of the studies.
* Ensures accurate and timely entry of all data in the CRF from the source notes, and tracks the flow of the CRF’s, queries, and patient recruitment statuses; reports out the flow of data.
* Maintains ISF and study trackers as delegated.
* Follows the QC process and checks that ICF’s are correctly completed.
* Ensures that protocol visit windows are scheduled according to the protocol requirements and reports deviations.
* QCs all supporting reports (laboratory reports/GP SDV/Consultant) to ensure they are reviewed and signed off by a physician within the appropriate timelines and flags any out of range values.
* Assists with archiving procedures if required.
* Assists monitors, sponsor representatives with the preparation of monitoring visits and query resolutions during monitoring visits.
* Identifies quality issues (QI) and reports them, and applies CAPA reporting and root cause analyses.
* Prepares and collates regulatory documents for submission.
* Interprets 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.
To be considered for this exciting opportunity you will require the following skills and experience:
* Fluent in English
* Good time management and multitasking skills in order to coordinate several studies with a number of participants simultaneously
* Appropriate MS Office Skills
* Good attention to detail
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.
#J-18808-Ljbffr