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.

Role Details:

We are recruiting for our sponsor-dedicated business in Latvia and are currently seeking to hire a CRA II with a permanent and full-time contract.

Our positions offer excellent exposure to a range of disease areas, and a real opportunity for career progression and promotion in time.

You will have autonomy to organize your work and in return, you will be supported and empowered to go beyond the typical CRA role, to really be an expert on your protocols and to own your sites.

Responsibilities include but are not limited to:

Responsible for all aspects of study site monitoring 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
Responsible for all aspects of site management as prescribed in the project plan.

Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study

Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements

Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review

Monitor data for missing or implausible data

Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines

Ensure audit readiness at the site level

Prepare accurate and timely trip reports

Responsible for all aspects of registry management as prescribed in the project plans

Undertake feasibility work when requested

Participate in and follow up on Quality Control Visits (QC) when requested

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

Might be requested to work in a client facing environment

Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE

Independently perform CRF review

Education and Qualifications:

We are searching for a university graduate with a life science degree or nursing background who relishes working in a fast paced environment, on complex and demanding protocols.

If you are someone who is eager to constantly develop and improve while working in a friendly and collaborative team environment; then we are looking forward to meeting you.

For CRA II position, 2+ years of independent monitoring experience in international Pharma/CRO company is needed
Experience in interventional studies
Excellent understanding of Serious Adverse Event (SAE) reporting
Fluent in English and local language

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