Clinical Research Associate Ii

Clinical Research Associate II
United States - Central Region, NJ, NY, PA, or FL
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 CRA II to be responsible for all aspects of study site monitoring and management including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
Additional responsibilities include:

• Organize and make presentations at Investigator Meetings
• Participate in the development of protocols and Case Report Forms as assigned
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned
• Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
• Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management

Requirements:

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
• COVID-19 vaccination required
• Minimum of at least 1 year of Onsite Clinical Monitoring experience along with at least 1 year total in Clinical Research experience is required.
• Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements
• Thorough knowledge of monitoring procedures; Basic understanding of the drug accountability process
• Valid Driver's License
• Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Good planning, organization and problem-solving abilities; Ability to work with minimal supervision

Pay Range: $90,000 - $125,000/year
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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