Data Compliance Coordinator- AES

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? Are you interested in the dynamic clinical research industry?

We are currently looking to recruit a Data Compliance Coordinator for our clinical site in Birmingham.

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:

• Acts as a core operational compliance specialist on several studies to ensure the successful delivery of projects
• Participates in the start-up, set-up and close out of projects, ensuring adherence to the client and company expectations.
• Ensures accurate and timely entry of all data in the CRF from the source notes and track the flow of the CRF’s, queries and patient recruitment status and report out the flow of data, where applicable.
• Maintains ISF and trackers as delegated.
• Ensures patient visits are within visit windows, as per protocol, and reports deviations.
• Assists with archiving procedures, if required.
• Serves as a liaison with monitors and client representatives and completes preparations for monitoring visit duties and audits.
• Ensures prompt response within agreed timeframes to data clarification requests.
• Identifies quality issues (QI) and reports it as required
• Ensures Company Procedures and Site SOPs are adhered to and gives clarity and guidance to others in the implementation thereof.
• Reviews informed consent forms for completion and escalates concerns to management.
• Ensures adherence to rules and regulations of ICH, GCP and other regulatory and ethical guidelines as well as data protection regulations.
• Reports any non-compliance of service level agreements.
• Highlights auditor findings and proposes CAPA actions and root cause analyses.
• Responsible for audit preparation and ensuring the audit readiness of site files.
• Identifies trends in data queries.
• Provides guidance on functional GCP, and other compliance and quality related topics, as required, to improve quality and expertise within the site.
• Identifies quality compliance training needs of site staff and provides training, as required (i.e., data systems, ISF) and assists with induction of new site staff.

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!

#LI-TK2 #AES