Operational Compliance Associate II

Job Profile Operational Compliance Associate II- part time, home-based for regular UK travel

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.

We are currently seeking a Operational Compliance Associate II to join our diverse and dynamic team. Firecrest Clinical is part of the ICON plc Group and produces highly visual and engaging products for the Clinical Trial Industry. Firecrest products help improve Site performance by delivering innovative and effective training to sites while complying with Industry Standards. As an organisation responsible for the development of clinical training for medical staff, the Content and Functional Reviewer role is critical to the delivery of accurate and high quality training products to our clients.

• Working within the Quality Department, with supervision from Senior Manager Quality Assurance, you will assist the Quality Department in all areas but not limited to:
• Execute an operational quality framework within the regional (UK) business including the Quality checking of clinical documentation at Accellacare investigator sites.
• Support Quality Issues process, facilitation of root cause analysis sessions and development and implementation of associated CAPA.
• To collate metrics on data generated within the Quality Team and provide required metrics to People Leader as required. To provide consultation on operational quality, risk and regulatory and legislative compliance to sites / functional departments.
• Tracking and support to external client audits and regulatory inspections.
• To be part of the Quality team and assist the business, the culture, the values and the wellbeing of the employees and the company in all areas.
• To drive and deliver operational quality and process improvement initiatives, training and compliance across the sites to increase operational quality, efficiency and long-term business success.
• To work with Accellacare personnel to improve and implement globally working practices and systems, in compliance with GCP and appropriate regulations to ensure best practices are achieved.
• Operational Quality
• Maintain a quality and compliance role, to provide quality focused support to the business so that regulatory compliance and commercial objectives are achieved.
• Perform compliance visits at Accellacare dedicated and affiliated site to review study data and associated clinical trial documentation. Issue visit reports to sites and follow-up findings and queries to resolution.
• Support operational staff with the reporting of Quality Issues and investigations.
• Categorise and classify Quality Issues in accordance with relevant procedures.
• Facilitate and report root cause analysis sessions on significant Quality Issues to aid CAPA definition and process improvement, where applicable.
• For Quality Issues, support operational staff with Corrective Action and Preventive Action Plan (CAPA) definition to ensure adequacy, robustness and compliance with Standard Operating Procedures (SOPs), regulations and best practice.
• In conjunction with CAPA coordinators and owners ensure quality findings and resultant CAPAs are addressed, implemented and effective. Escalate issues to People Leader as required.
• Identify Operational Quality performance measures, collate metrics on data generated within Operational Quality and provide required metrics to management, as appropriate.
• Support the Quality Team with regards to notification, preparation and facilitation of client audit and regulatory inspections, investigations of Quality issues and tracking and follow up of regional CAPA status ensuring on time completion of quality related tasks.
• Ensure operational quality, patient safety and data integrity are at the forefront of all activities through review and interpretations of quality reports (e.g. Operational Quality reports, audit reports, Quality Issue forms, inspection output, complaints) and specific activities undertaken via regional Operational Quality.
• Maintain effective relationships internally and externally, for efficient and effective delivery of service.
• Comply with company quality framework, regulatory (GCP) legislation, guidelines and international standards.
• Safeguard confidentiality of staff, patient and client matters as required by regional Data Protection and Good Clinical Practice expectations.
• Provide administrative support to Quality team processes e.g. tracking of external audits, regulatory inspections etc.
• Provide Quality metrics (as required)
• Assist with SOP reviews as coordinator, responsible for ensuring that SOPs are reviewed in a timely manner by the Process owner and follow up with relevant reviewers and document control to ensure they are made effective in the system.
• Perform any other duties as required to support the Quality team and wider Accellacare business.

• A degree or relevant qualification e.g. diploma, certificate, or relevant experience in clinical trials.
• Minimum 2 years’ experience in a clinical research role within a Site Management Organisation, Clinical Research Organisation, NHS, Academia, or pharmaceutical business.
• Bachelor’s degree in a Scientific Subject
• Working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.
• Willingness to travel regionally on a regular basis (approximately 20%).
• Excellent word and excel skills and preferably experience of preparing an analysing data.
• A demonstrated commitment to quality in a regulated environment.
• Ability to work independently, with minimal supervision, and be confident to make local decisions and escalate accordingly.
• Exceptional customer services skills to both internal and external stakeholders.
• Be highly organised with a focus on quality and detail.
• Self-motivated with a high level of initiative
• Assertive and persistent with a high degree of flexibility
• Excellent communication and interpersonal skills and the ability across the organisation at all levels

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.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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