Operational Compliance Associate II

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.

If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Title: Operational Compliance Associate II

Location: US (East Coast specifically, it is ideal for the candidate to be local or near Winston Salem NC to occasionally be on site)

Duties:

• To assist the Quality Department in all areas but not limited to:
  • Execute an operational quality framework within the regional (USA) 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.

Key Accountabilities:

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.
• Review data and associated clinical trial documentation at sites to assess compliance to required standards.
• Support operational staff with the reporting of Quality Issues and investigations.
• Categorize 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.
• Provide training on GCP, and other compliance and quality related topics, as required to improve quality and expertise within the operation of the regional research centers.
• Safeguard confidentiality of staff, patient and client matters as required by regional Data Protection and Good Clinical Practice expectations.

• Provide administrative support and /or onsite support to Quality team processes e.g. tracking of external audits, regulatory inspections etc.
• Provide Quality metrics (as required)

• Perform any other duties as required to support the Quality team and wider Accellacare business.

To be successful, you will have:

• A degree or relevant qualification e.g. diploma, certificate, or relevant experience in clinical trials
• Minimum 1 years’ experience in a clinical research role within a Site Management Organization, Clinical Research Organization or Pharmaceutical business.
• Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.
• Knowledge of maintaining and improving quality systems and procedures
• Prior experience in a Quality role within clinical research ideally with knowledge of performing Quality checks or audits of data.
• Willingness to travel regionally on a regular basis.
• Excellent word and excel skills and preferably experience of preparing an analyzing data
• Exposure to client audits and regulatory inspections, ideally in a Quality role
• 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.

Benefits of Working in ICON:

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

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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, 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 through the form below.