- 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.
- 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
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Data Compliance Coordinator - Chorley, United Kingdom - Thermo Fisher Scientific
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.
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 Chorley, Lancashire.
Working 37 hours a week, Monday to Friday, this role will be responsible for oversight of data and quality control to 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:
To be considered for this exciting opportunity you will require the following skills and experience:
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.
