Sr. Clinical Research Associate

About the role

The Sr. Clinical Research Associate (Sr. CRA) is responsible for overseeing 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).

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.

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 0-2 years 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

Essential Requirements

• Ability to travel 20-70%– including overnight(s), within the US. Travel may be up to 70% during project initiation periods
• Previous experience in: - Retrospective/prospective biological sample procurement - Experience with electronic Trial Master Files and Clinical Trial Management Systems - CLSI guidelines and Good Laboratory Practice (GLP)

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.

Pay

The annual salary range OR the hourly range for this role is $103,000.00 - $130,000.00. 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.

Equal Opportunity Employer

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.