Operational Compliance Associate II- part-time, fixed-term contract

Operational Compliance Associate II- part-time, fixed-term contract

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Operational Compliance Associate

Coventry or Home Based with regular UK travel

Part-time, 26.25hrs/ week

This is a maternity cover for one year

The Accellacare Quality department are looking for a motivated, detail orientated individual with Good Clinical Practice (GCP) experience to join their team as an Operational Compliance Associate. This role will give you the opportunity to travel to sites across the UK to perform Quality checks on the clinical data and associated documentation and to support the sites with any Quality Issues, associated corrective and preventative action plans and participation in audits and regulatory inspections.

What you will be doing:

• Perform Quality checks on clinical documentation across Accellacare UK investigator sites to assess compliance and prepare reports on outcomes within agreed timelines.

• Support staff with the reporting and thorough investigation of Quality Issues and with the development of a robust and measurable corrective and preventive actions (CAPA) for any Quality Issues identified

• Facilitate and report root cause analysis sessions on significant Quality Issues to aid CAPA definition and process improvement, where applicable

• Support staff with regards to the notification, preparation and facilitation of client audits and regulatory inspections

• To collate metrics on data generated within the Quality Team and provide required metrics to People Leader/site staff as required.

What you will have:

• Experience in a clinical research role within a Site Management Organisation, Clinical Research Organisation or Pharmaceutical business.

• Be highly organised with a focus on quality and detail with excellent communication and interpersonal skills

• Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.

• Excellent word and excel skills and preferably experience of preparing and analysing data

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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply