As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.
At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 15,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.
• Supports and executes (may develop and maintain) trial oversight activities for assigned trials/indications to ensure quality in the execution of clinical trials, compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness.
• Support pre-study activities, contributing to the review of key risks in the clinical protocol and advising clinical team members on effective mitigation strategies.
• Ensure that selection of investigator sites balances benefits against potential risks and that rationale for decisions are well documented.
• Monitors risks and mitigations during study execution. Prepares periodic reports assessing critical to quality parameters for the trial and reviews these reports with applicable clinical team members to evaluate pre-defined areas of risk and/or identify new areas of risk.
• Assist in the execution of the Integrated Quality Plan (IQP), in collaboration with the QP&S IQP leader, Program Leader and Trial Oversight Managers.
• Assist in (may lead) the preparation of Quality Working Group (QWG) meetings.
• Assists in the development of materials for Stage Gate Review, as needed.
• Provides ongoing compliance guidance to applicable clinical team members on an ongoing basis. Liaises with QPS Program Leads / Managers and other members of BRQC, as appropriate, to ensure interpretation alignment and consistency with guidance provided.
• Support inspection readiness for the clinical trial, and provides support during sponsor-monitor inspections, as needed.
• Support escalation of significant quality issues according to company policy and SOPs and in collaboration with the clinical team, and BRQC Peers, to ensure timely issue resolution.
• May support the develop and implement Corrective and Preventative Action Plans (Self-Identified, Inspection).
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.