Job Description

Senior Clinical Research Associate II, FSP

USA - OH/IN/KY/MI

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\xe2\x80\x99s 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 .

Why settle for one thing when you can have everything? Fortrea gives you the best two for one opportunity for career growth. Who doesn\xe2\x80\x99t want twice the perks \xe2\x80\x93 working at one of the largest FSP CROs \xe2\x80\x94 and partnering with one sponsor with a dedicated therapeutic focus. Dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance we have an FSP opportunity to match your area of expertise.

You will enjoy the best of both worlds \xe2\x80\x94 all the benefits that come along with our Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor using their systems and processes. This also comes with the benefit of bringing your strong therapeutic experience to a single protocol or sponsor portfolio. This allows your expertise to shine through as you also become engrained in the sponsor culture helping to bring more therapies out to patients. Our FSP model is flexible and scalable. Our teams are collaborative and proactive \xe2\x80\x93 a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research. Our reach is global \xe2\x80\x93 extending to 60+ countries making us one of the largest FSP CROs. So not matter where you are locating on the globe we have an FSP opportunity for you.

We are seeking a Sr. 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 and clinical trial reports 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

Travel, including air travel, may be required and is an essential function of the job; prepare accurate and timely trip reports; review progress of projects and initiate appropriate actions to achieve target objectives

Conduct, report and follow-up on Monitor Quality Control Visits (MQC) or Quality Control Visits (CQC) when requested

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.

Minimum of at least 3-4 years of Onsite Clinical Monitoring experience. At least 1 year additional experience in a related field is preferred.

Advanced site monitoring; study site management; and registry administration skills.

COVID-19 vaccination required

Valid Driver\'s License required

Ability to train and supervise junior staff; resolve project related processes.

Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements

Thorough knowledge of monitoring procedures; Basic understanding of the drug accountability process

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

Covid-19 Vaccination Required

Pay Range: $120,000 - $155,000/year

Benefits: All job offers will be based on a candidate\xe2\x80\x99s 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 .

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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