Senior Clinical Research Associate

Hbcu Connect, Llc; New York (NY); Remote; USD 103,000 - 130,000; Full time

Job summary

Danaher Diagnostics is seeking a Sr. Clinical Research Associate to lead IVD/medical device trials at external sites across the United States. You will handle startup, initiation, monitoring, and close-out with emphasis on data integrity and compliance with FDA/GCP.

This fully remote role reports to Global Clinical Affairs and focuses on building relationships with investigators, vendors and internal stakeholders while supporting study planning, budgeting and regulatory documentation.

Qualifications

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

Responsibilities

• 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, internal stakeholders, and vendors
• Conduct independent study monitoring, site coordination, product accountability, and assessments of deviations/adverse events
• Manage IRB submissions and regulatory documentation to keep Trial Master File audit-ready
• Contribute to study planning, budgeting, contracts, timelines, and process improvements

Skills

Clinical research

Regulatory knowledge

IRB submissions

Data integrity

Multitasking

Education

Bachelor's degree in life sciences

Master's degree in life sciences

Doctoral degree with clinical research experience

Tools

eTMF

CTMS

Job description

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 livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement, you help turn ideas into impact innovating at the speed of life.

Were accelerating the development of cutting-edge diagnostics to solve some of the worlds 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. were bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together, were expanding access to precision diagnostics for millions of people worldwide - and were 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, were improving treatment options and saving lives.

Learn about the Danaher Business System which makes everything possible.

TheSr. Clinical Research Associate(Sr. CRA)is responsible forset-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 positionreports to theManager, Clinical SiteOperationsandis part of theGlobal Clinical Affairs organization. The position will be fully remote within the United States.

In this role, you will have the opportunity to:

• Oversee clinical study protocol execution at external sites, from start-up to close-out, ensuringtimelydata collection and compliance with FDA standards and Good Clinical Practice (GCP)
• Develop andmaintainrelationships with institutions, study investigators, internal stakeholders, and vendors to ensure successful trial execution, dataintegrityand adherence to project requirements
• Conductindependentstudy monitoring, including site coordination, investigational product accountability,andassessments of protocol deviations and/or adverse events, and driveclinical data qualitywhich canincludefollow up on incomplete data entry and/or outstanding queries
• Manage IRB submissions and all study regulatory documentationtoensure Trial Master File is kept up to date and audit ready
• Contribute to study planning including budgetand contract negotiationand 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.

The essential requirements of the job include:

• Bachelors degree with 5+ years clinical research experience OR Masters degree with 3+ years clinical research experienceOR 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

• Previousexperience with managing clinical research sites andmonitoringclinical study data

• Good technical background to understand and communicate current andnew technologies

• Ability to work on multiple projects simultaneously

Travel Requirements:

• Ability to travel 20-70% includingovernight(s), 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:

• Retrospective/prospective biological sample procurement
• Experience withelectronicTrial Master Filesand Clinical TrialManagement 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.

Within Danaher Diagnostics, we offer a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether its 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 $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.

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 Companys sole discretion, consistent with the law.

Join our winning team today. Together, well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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.

The U.S. EEO posters are available here.

For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].