Clinical Project Coordinator I

Clinical Project Coordinator I

Remote – United States of America

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 www.fortrea.com.

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.

We are seeking a remote-based Clinical Project Coordinator who will perform tasks related to supporting operational strategy, planning, and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.

• Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the CTA Manager.
• Perform departmental tasks as needed.
• (CROs) to support clinical study activities as defined by the clinical trial operating model.
• Collaborate with Clinical Operations Manager, study teams, and Clinical Research Organizations
• Perform developmental tasks as appropriate with oversight of CTA Manager.

Responsibilities:

• Supporting/oversight of risk-based monitoring.
• Supporting additional ad-hoc activities as needed, as agreed with CTA Manager.
• Review and/or approval of study documentation, including essential document packets, study plans, informed consent forms, etc.
• Supporting regulatory inspection readiness (e.g., preparation of materials and/or participation during regulatory inspections.)
• Attendance of key team meetings as required; may make presentations (e.g., data, etc.).

For all assigned studies, provide support including:

• Participating in functional initiatives and/or working groups.
• Provide updates to applicable CTA resources as needed.
• Supporting vendor contract administration as required.
• Supporting new CTA team member onboarding.
• Supporting Health Care Provider Engagement for facilitating contracts and meetings.
• And processes; provide presentations, training, and support to CTA team as needed;
• Provide support for departmental tasks, including but not limited to:
• Maintaining knowledge and acts as team super-user or subject matter expert for related systems
• Escalation of clinical trial insurance issues.
• Perform developmental tasks as appropriate with oversight of CTA Manager, including:
• External vendors.
• Targeted skill development and/or growth of knowledge base.
• Collaboration with internal departments (Legal, Insurance, R&D functions, etc.), CROs, and
• Career development and goal setting.
• Assisting with special projects and/or tasks as required.

Requirements:

Education:

• Bachelor’s degree or equivalent international degree required.

Experience:

• Experience in Phase 2 and 3 studies and global/international studies is advantageous.
• 1-2 years’ experience in pharmaceutical industry, clinical research organization, or related role.
• Experience working across multiple therapeutic areas (including oncology) is advantageous.

Skills

• Demonstrated excellence in task management and cross-functional collaboration.
• Knowledge in global/regional regulatory and compliance requirements for clinical research.
• Excellent teamwork, organizational, interpersonal, and problem-solving skills.
• Fluent business English (oral and written).
• Excellent communication skills.

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Labcorp is proud to be an Equal Opportunity Employer:

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