Clinical Quality Compliance Specialist

Act as an expert advisor on ICH GCP, ICON SOPs/WPs and all stages of study set-up, monitoring and study close-out for assessment of quality compliance processes for monitoring activities. Become involved, when required, in other areas of services and staff training and contribute to the review of ICON systems and quality procedures as appropriate .Assist in tracking and trending departmental quality compliance in processes and departmental metrics. Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.

* As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
* Assist the relevant operational staff in the development and implementation of clinical quality plans at the department and study level.
* Assist with monitoring assessment of quality metrics and/or key quality indicators.
* Identify potential non compliance/breaks of quality control steps taken by operations as measured thru SOP, WP and industry standards
* Escalation as appropriate to senior management with proposed solutions
* Assessment of quality compliance processes for TMF to identify gaps, assist with corrective measures.
* Assess and assist project teams with quality control processes for monitoring trip reports and review for selected studies to ensure the monitoring plan is followed , issues are resolved an/or escalated and cycle times are achieved .
* Oversee implementation and tracking of appropriate standard metrics of quality monitoring and may personally conduct on-site co-monitoring visits.
* Review of deliverables in conjunction with issues that are affecting the quality of the clinical deliverables to ensure quality standards are achieved.
* Prepare reports of trends in Clinical QC findings for management.
* Assist in the development of corrective and preventative action plans for the department when required.
* Train new Clinical Quality Compliance staff on processes and procedures.
* Provide QC services to other operational departments/vendors, as required.
* Scheduling and managing internal and external meetings, assisting in the production of presentation materials, generating meeting minutes.
* Contacting external and internal individuals to collate relevant study information.