Project Coordinator I

Clinical Project Coordinator (Clinical Study Associate)

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 (Clinical Study Associate) 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.
• Collaborate with Clinical Operations Manager, study teams, and Clinical Research Organizations
• (CROs) to support clinical study activities as defined by the clinical trial operating model.
• Perform departmental tasks as needed.
• Perform developmental tasks as appropriate with oversight of CTA Manager.

Responsibilities:

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

For all assigned studies, provide support including:

• Collaboration with internal departments (Legal, Insurance, R&D functions, etc.), CROs, and
• external vendors.
• Escalation of clinical trial insurance issues.
• Supporting Health Care Provider Engagement for facilitating contracts and meetings.
• Supporting vendor contract administration as required.
• 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
• and processes; provide presentations, training, and support to CTA team as needed;
• provide updates to applicable CTA resources as needed.
• Participating in functional initiatives and/or working groups.
• Assisting with special projects and/or tasks as required.
• Supporting new CTA team member onboarding.
• Perform developmental tasks as appropriate with oversight of CTA Manager, including:
• Career development and goal setting.
• Targeted skill development and/or growth of knowledge base.

Requirements:

Education:

• Bachelor’s degree or equivalent international degree required.

Experience:

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

Skills

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

Pay Range: $25.75 - $35.00 hourly

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable . For more detailed information, please click here .

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Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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Salary : $26 - $35