CRA, sponsor dedicated

Labcorp; Rueil-Malmaison; À distance; EUR 45 000 - 70 000; Plein temps

Résumé du poste

Labcorp is seeking a Clinical Research Associate (CRA) specializing in site management, responsible for various aspects of clinical trials across therapeutic areas including oncology. This role offers a competitive salary, flexible working arrangements, and opportunities for career development within a leading global organization.

Prestations

Flexible working hours

Capped overtime and compensatory time off

100% home-based permanent employment

Regular merit-based salary adjustments

Extensive insurance coverage

Training and career development opportunities

Qualifications

• Solid independent monitoring experience in France as CRA with a focus on complex clinical trials (phases II and III).
• Proven experience in therapeutic areas including oncology.
• Awareness of clinical research regulatory requirements.

Responsabilités

• Oversee all aspects of site management as outlined in project plans.
• Ensure study staff receive all materials to safely enter patients in the study.
• Protect study patients by verifying adherence to informed consent procedures.

Connaissances

Communication skills in French and English

Time management

Organizational skills

Attention to detail

Formation

Degree in life sciences, biology, health care, nursing, pharmacology, or medicine

Outils

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

eTMF solutions like Veeva Vault

Description du poste

Clinical Research Associate CRA - sponsor-dedicated

Location: Paris / France with flexibility

Oncology expertise is a plus

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.

In this role, you will work directly with one of our renowned key sponsors and advance the development of innovative, life-changing medications for therapies across a wide spectrum of indications: oncology, vaccines, cardiovascular, neurology, etc. If you are looking to broaden your therapeutic expertise whilst gaining exposure within a world-class pharmaceutical working environment, this is an excellent opportunity!

What you can expect from us:

• flexible working hours, capped overtime and compensatory time off in lieu
• 100% home-based, permanent employment contract with Labcorp Drug Development
• highly competitive compensation packages
• subsidized meals and transportation allowances
• regular, merit-based salary adjustments
• significant employer contribution to an attractive pension scheme
• extensive insurance coverage, including medical, life, short as well as permanent disability and accidents
• excellent training and career development opportunities as well as support with furthering your education
• strong support from Line Management and more than 20'000 colleagues worldwide
• the world's most renowned pharmaceutical companies as our satisfied, repeat customers for many years

Your responsibilities:

• Own all aspects of site management as described in the project plans.
• Ensure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the study.
• Protect 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 diligently reviewing source documents. Monitor data for missing or implausible entries.
• Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; submit accurate and timely trip reports.
• Review progress of projects and initiate appropriate actions to achieve target objectives.
• Act as a primary contact for clinical trial suppliers and other vendors.
• Own the entire process of Serious Adverse Event (SAE) reporting
• Generate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems

Education& Experience:

• Solid independent monitoring experience in France as (Senior / Lead) CRA, with a focus on complex clinical trials (phases II and III)
• Proven experience in a variety of therapeutic areas, preferably including oncology
• Awareness of applicable clinical research regulatory requirements such as local regulations, GCP / ICH and the French regulatory authorities landscape
• IT-literate, including Microsoft Word, Excel, PowerPoint, and preferably eTMF solutions such as Veeva Vault
• Effective time management and organizational skills and a keen attention to detail
• Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders
• Excellent communication skills in both French and English - spoken and written - are a must
• Degree in a relevant field such as life sciences, biology, health care (management), nursing, pharmacology, (veterinarian) medicine etc.
• In lieu of the above, a valid certification in health / life sciences by an accredited institute

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 .

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.

For more information about how we collect and store your personal data, please see our Privacy Statement .

About the company

Laboratory Corporation of America Holdings, more commonly known as Labcorp, is an American S&P 500 company headquartered in Burlington, North Carolina.

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