Senior Clinical Research Associate

Danaher; United States; Teletrabalho; USD 90 000 - 130 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Benefits program

Resumo da oferta

Danaher Diagnostics is seeking a Sr. Clinical Research Associate to lead set-up, initiation, execution, monitoring, and close-out of IVD and medical device trials at external sites within the United States. The role requires independence in training and managing external sites and reports to the Manager, Clinical Site Operations.

The position is fully remote in the U.S. and involves travel; essential experience includes regulatory knowledge, GCP, and site management.

Qualificações

• Bachelor’s degree plus 5+ years clinical research experience, or higher degrees with related experience.
• Knowledge of regulatory requirements and Good Clinical Practice for in vitro diagnostic and medical device products.
• Experience managing clinical research sites and monitoring study data.
• Ability to work across multiple projects and communicate current technologies.

Responsabilidades

• Oversee protocol execution at external sites from start-up to close-out, ensuring data collection and GCP compliance.
• Develop and maintain relationships with institutions, investigators, and vendors for trial success and data integrity.
• Conduct independent study monitoring and assess deviations and adverse events; drive data quality.
• Manage IRB submissions and Trial Master File to ensure audit readiness.
• Assist study planning including budgeting, contracts, timelines, site selection, and templates creation.

Conhecimentos

Regulatory knowledge

Clinical research experience

Project management

Communication skills

Travel readiness

Formação académica

Bachelor's degree

Master's degree

Doctoral degree

Ferramentas

EDC software

CTMS

TMF systems

Descrição da oferta de emprego

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? Within Danaher the work our diagnostic businesses do saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. We're accelerating the development of cutting-edge diagnostics to solve some of the world's most pressing health challenges. Across our diagnostics operating companies we are driving innovation through partnerships with top academic institutions and leading players in biopharma and translational research. We're bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together, we're expanding access to precision diagnostics for millions of people worldwide - and we're using our unmatched global scale and proven playbook to make it happen, from hospital labs to mobile clinics. By helping providers, patients, and families get faster, more precise diagnostic results, we're improving treatment options and saving lives. Learn about the Danaher Business System which makes everything possible.

Role Overview

The Sr. Clinical Research Associate (Sr. CRA) is responsible for set-up, initiation, execution, monitoring and close-out of IVD and medical device clinical trials at external clinical research sites and/or laboratories. The Sr. CRA should be able to independently train and manage external clinical research sites. This position reports to the Manager, Clinical Site Operations and is part of the Global Clinical Affairs organization. The position will be fully remote within the United States.

Key Responsibilities

• Oversee clinical study protocol execution at external sites, from start-up to close-out, ensuring timely data collection and compliance with FDA standards and Good Clinical Practice (GCP)
• Develop and maintain relationships with institutions, study investigators, internal stakeholders, and vendors to ensure successful trial execution, data integrity and adherence to project requirements
• Conduct independent study monitoring, including site coordination, investigational product accountability, and assessments of protocol deviations and/or adverse events, and drive clinical data quality which can include follow up on incomplete data entry and/or outstanding queries
• Manage IRB submissions and all study regulatory documentation to ensure Trial Master File is kept up to date and audit ready
• Contribute to study planning including budget and contract negotiation and timeline forecasts, site identification and qualifications, and process improvement initiatives within the Global Clinical Affairs organization; as well as prepare study documents, including creating clinical templates, such as informed consent forms, clinical monitoring plan, etc.

Essential Requirements

• Bachelor's degree with 5+ years clinical research experience OR Master's degree with 3+ years clinical research experience OR Doctoral degree in field with clinical research experience
• Basic knowledge of regulatory requirements and Good Clinical Practice for in vitro diagnostic and medical device products
• Previous experience with managing clinical research sites and monitoring clinical study data
• Good technical background to understand and communicate current and new technologies
• Ability to work on multiple projects simultaneously

Travel Requirements

Ability to travel 20-70% - including overnight(s), within the US. Travel may be up to 70% during project initiation periods.

Preferred Experience

• Retrospective/prospective biological sample procurement
• Experience with electronic Trial Master Files and Clinical Trial Management Systems
• Demonstrated understanding of CLSI standards and their application to IVD clinical studies, including method comparison, precision/reproducibility, reference interval, specimen stability, clinical performance, and point-of-care evaluations.

Benefits

Within Danaher Diagnostics, we offer a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Remote Work Arrangement

Within Danaher Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibil