Clinical Trial Assistant

Danaher Corporation

1d • $70,000 - $80,000 • Remote

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Biosystems, one of Danaher’s 15+ operating companies, our work 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. At Leica Biosystems, we’re not just shaping the future of cancer diagnostics — we’re transforming lives. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you’re not just taking a job; you’re becoming part of a passionate team that knows every moment matters when it comes to cancer. You’ll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you’ll be inspired each day to stretch, grow, and make an impact. Learn about the Danaher Business System which makes everything possible. The Clinical Trial Associate is responsible for supporting preparation, collection and filing of clinical trial documentation relating to the Trial Master File (TMF) as well as providing operational support to activities required for successful clinical study planning, execution and close-out. This position will work closely with Clinical Research Associates (CRAs) and Clinical Study Managers (CSMs) to ensure adherence to Good Clinical Practice (GCP) and department standard operating procedures. This position reports to the Manager, Clinical Site Operations and is part of the Clinical Center of Excellence within Danaher Diagnostics. At Danaher Diagnostics, our vision is to be the leading provider of seamlessly connected diagnostic solutions. The position will be fully remote within the United States. In this role, you will have the opportunity to: Maintain and organize essential trial documentation including regulatory binders, lab manuals, and investigator site files in compliance with Good Clinical Practice (GCP), ICH, and applicable SOP and regulatory standards. Support clinical data collection by tracking sample shipments, logging case report forms (CRFs), and updating study trackers for IVD performance metrics. Assist in managing biological sample inventory, shipment coordination, and reconciliation of sample tracking logs specific to IVD and medical device testing. Help prepare and submit documentation for IRB/EC approvals, including informed consent forms and study protocols. Schedule and support study meetings, teleconferences, and training sessions, including preparation of agendas and distribution of minutes. Assist in preparing for and supporting audits and inspections of clinical trial master files Build and maintain the eTMF system, including review of standard work processes associated with the eTMF system

Requirements

• Bachelor’s degree in health sciences, health science background or demonstrated employment equivalency to role.
• Strong organizational and time management skills to prioritize tasks effectively.
• Flexibility to adapt to changing priorities and deadlines.
• Travel Requirements: Minimal, ability to travel 10%– including overnights, within the US.

Nice To Haves

• Good Clinical Practice (GCP)
• Electronic Trial Master File (eTMF)

Responsibilities

• Maintain and organize essential trial documentation including regulatory binders, lab manuals, and investigator site files in compliance with Good Clinical Practice (GCP), ICH, and applicable SOP and regulatory standards.
• Support clinical data collection by tracking sample shipments, logging case report forms (CRFs), and updating study trackers for IVD performance metrics.
• Assist in managing biological sample inventory, shipment coordination, and reconciliation of sample tracking logs specific to IVD and medical device testing.
• Help prepare and submit documentation for IRB/EC approvals, including informed consent forms and study protocols.
• Schedule and support study meetings, teleconferences, and training sessions, including preparation of agendas and distribution of minutes.
• Assist in preparing for and supporting audits and inspections of clinical trial master files
• Build and maintain the eTMF system, including review of standard work processes associated with the eTMF system

Benefits

• Leica Biosystems, a Danaher operating company, offers 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.
• The annual salary range for this role is $70,000 - $80,000.
• This job is also eligible for bonus/incentive pay.
• We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level