Job Description
PPD, now Thermo Fisher's clinical research business, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.
At PPD, we are passionate, deliberate, and driven by our purpose - to improve health!
Accelerated Enrollment Solutions (AES) is a business unit of PPD that helps biopharmaceutical companies overcome patient recruitment and research site challenges by optimizing each step in the patient journey to deliver greater speed, certainty, and control to clinical trial delivery.
Do you have a data entry/quality compliance background?
Interested in the dynamic clinical research industry?
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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:
- 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.
- Assist 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 to 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:
- 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
Our 4i Values:
Integrity - Innovation - Intensity - Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application - we'd love to hear from you!