The Clinical Research Associate II 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.
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.
In this role, you will have the opportunity to: - Lead clinical study execution across external sites from start-up through close-out, ensuring protocol compliance, timely data collection, issue resolution, and adherence to GCP and regulatory requirements.
- Build and maintain collaborative relationships with investigators, institutions, vendors, and cross-functional stakeholders to support study delivery, data integrity, and project objectives.
- Conduct study monitoring activities, including site oversight, investigational product accountability, and management of protocol deviations and adverse events, driving appropriate corrective and preventive actions.
- Manage IRB/IEC submissions, amendments, and study regulatory documentation, ensuring completeness and compliance with applicable regulations.
- Support study planning and execution through site identification, qualification, activation, contract and budget negotiations, and continuous process improvement initiatives within Global Clinical Affairs.
The essential requirements of the job include: - Bachelor's degree (Life Sciences, Healthcare, or a related field preferred) with 3+ years clinical research experience OR Master's degree in field with 2+ years of related work experience, or demonstrated employment equivalency
- Proven knowledge of regulatory requirements and Good Clinical Practice
- Experience with in vitro diagnostic (IVD) and medical device clinical trials (preferred)
- Strong technical background with ability to utilize current and emerging technologies
- Ability to work on multiple projects simultaneously
Travel Requirements: - Ability to travel 20-70%- including overnights, within the US. Travel may be up to 70% during project initiation periods
It would be a plus if you also possess previous experience in: - Experience with electronic Trial Master Files (eTMF), Electronic Data Capture (EDC) systems, and Clinical Trial Management Systems (CTMS)
- CLSI guidelines and Good Laboratory Practice (GLP)
- Neurological Disease Research
Within Danaher Diagnostics, weoffer 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.
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 flexibility and challenge that working within Danaher Diagnostics can provide.
The annual salary range OR the hourly range for this role is $75K-$95K. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
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.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
