Clinical Quality Control Oversight Representative, Clinical Operations

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Did you know?

Labcorp's Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea’s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.

Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit [Register to View] .

Why settle for one thing when you can have everything? Fortrea gives you the best two for one opportunity for career growth. Who doesn’t want twice the perks – working at one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus.

Our Energizing Purpose, Exceptional People and Extraordinary Potential combined with collaborative and proactive teams offer a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research. Our reach is global – extending to 60+ countries making us one of the largest FSP CROs. So, no matter where you are located on the globe, we have an FSP opportunity for you.

The Clinical Quality Control Oversight Representative, Clinical Operations will coordinate and perform the comprehensive Quality Control Oversight (QCO) activities of CRO managed investigative sites. As needed, may also perform site management of clinical trials.

DUTIES AND RESPONSIBILITIES

• Oversee and evaluate CRO monitoring activities through electronic data capture (electronic diaries), patient enrollment, site monitoring, review of monitor visit reports and review of status in CRO CTMS.

• Training and oversight of other QCO representatives including contract/third party QCO representatives.

• Participate in CRO trainings and investigator meetings.

• Review CRO CRA and contract/third party QCO representative CVs.

• Point of contact for CRO for QCO activities and provide guidance on issue resolution.

• Participate in study team teleconferences with CRO as necessary, present findings from QCO visits and monitoring report review

• Liaise with CTM and CRO to create action plans based on QCO findings to improve monitoring quality.

• Coordination of monitoring report review and QCO visits in collaboration with the Global/Regional CTM.

• Perform QCO of CRO Monitor Visit Reports; enter any findings on the QCO Issues/Resolution Log and follow to resolution.

• Review QC visit reports conducted by contract/third party QCO representatives for assigned regions.

• Ensure all issues identified by QCO representatives are entered on the QCO Issues/Resolution Log and sent at prescribed intervals to the internal Shionogi and CRO study team.

• Conduct QCO visits at investigative sites, identify and follow-up on site action items, prepare QCO visit report.

• Interface with investigators, study coordinators, and study personnel via telephone, written correspondence, and on-site visits.

• Participate in targeted QC review of Trial Master File.

• As needed perform CRA Monitoring Responsibilities for clinical studies:

• Interface with investigators, study coordinators, and study personnel via telephone, written correspondence and on-site visits.

• Coordinate and disseminate information to site staff (i.e., study protocol, CRFs)

• Monitor study protocol(s). Collect and review regulatory documents and perform source document verification.

• Provide verbal reporting of any serious adverse events related to the study project.

• Complete QC trip reports and other required forms. Provide documentation for related correspondence.

MINIMUM JOB REQUIREMENTS

• Bachelor’s degree in a relevant field; R.N. or equivalent. At least 10 years minimum experience in clinical research monitoring, preferably including knowledge of multiple therapeutic areas of relevance to assigned projects.

• A minimum of 7 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting required.

• Analytical, negotiation, meeting management, cross-functional team, and leadership skills required as demonstrated from representation at a management level.

• Demonstrated ability to be versatile, serve as a role model to more junior clinical staff and a willingness to teach others as evidenced by a collaborative work style.

• Knowledge and proficiency of Microsoft Office: Word, Excel, PowerPoint

• Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.

• Strong working knowledge of Good Clinical Practices (GCPs) and pertinent U.S. FDA Code of Federal Regulations.

• Demonstrated ability to attend to detail, make effective presentations and work independently.

• Ability to travel independently by air, car and/or train.

• Willingness and ability to spend prolonged periods of time reviewing medical charts and data collection forms and utilizing a small screen laptop computer.