Senior Clinical Research Associate (Project Lead)

Posted 8 Days Ago
Be an Early Applicant
6 Locations
In-Office or Remote
103K-128K Annually
Senior level
Biotech
The Role
The Senior Clinical Research Associate will manage the full lifecycle of clinical studies, including monitoring, data oversight, and regulatory submissions in IVD clinical trials.
Summary Generated by Built In
Job TitleSenior Clinical Research Associate (Project Lead)
Location(s)
US Remote - MA, US Remote - MD, US Remote - NC, US Remote - NJ, US Remote - NY, US Remote - NYC, US Remote - TX

About Us

Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11,000+ colleagues from around the globe are vital to our success and the reason we’re able to push boundaries in pursuit of better human health.

Find your future at Revvity 

Overview:

Revvity is seeking a Senior Clinical Research Associate (Sr. CRA) to support global In Vitro Diagnostic (IVD) clinical trials. This role goes beyond traditional monitoring as you will be involved in the full lifecycle of clinical studies, including site startup, monitoring, data oversight, and preparation for regulatory submissions.

The ideal candidate is a hands-on clinical research professional who thrives in a multi-hat role: part CRA, part study coordinator, and part project contributor. You will have the opportunity to work across diverse diagnostic programs within a global Clinical Affairs team, supporting studies that directly impact patient care worldwide.

Why Join Revvity:

At Revvity, you will be part of a lean, high-impact global Clinical Affairs team driving the development of diagnostic solutions that improve patient care worldwide. This position offers the chance to step beyond traditional monitoring and gain broad exposure to regulatory submissions, data management, and study planning. Your contributions will be visible, valued, and essential to advancing our mission.

Key Responsibilities:

Clinical Study Execution

  • Contribute to study planning, feasibility, and protocol development

  • Identify, evaluate, and activate clinical trial sites

  • Support contract and budget coordination during site startup

  • Serve as a primary point of contact for site staff throughout the study

Monitoring and Oversight

  • Conduct site qualification, initiation, interim monitoring, and close-out visits Ensure compliance with protocol, ICH-GCP, FDA, and applicable local and global regulations

  • Verify informed consent and assent processes and patient protections, including pediatric populations

  • Apply risk-based monitoring strategies and escalate issues when needed

Data Quality and Reporting

  • Perform source document verification, CRF and eCRF review, and query resolution

  • Monitor study databases for accuracy, completeness, and data integrity

  • Collaborate with data management and biostatistics teams to resolve discrepancies

Cross-Functional Collaboration

  • Work closely with Global Clinical Affairs colleagues, regulatory, and operations teams to support study deliverables

  • Provide input into study documents and clinical operations planning

Basic Qualifications:
  • Bachelor’s degree in a scientific or healthcare field or RN/BSN AND a minimum 5 years of clinical research experience including independent monitoring AND
  • Experience in Type 1 Diabetes, infectious diseases, or newborn screening clinical studies AND in Vitro Diagnostic (IVD)

Preferred Qualifications:

  • Proficiency with CTMS, EDC, and Microsoft Office Suite
  • Strong organizational skills with the ability to adapt quickly and manage competing priorities
  • Excellent communication and problem-solving skills
  • Ability to collaborate effectively in a global, cross-functional environment
  • Ability to travel up to 25 percent for site visits and team meetings
  • Must possess U.S. work authorization
  • Demonstrated ability to manage clinical sites across multiple phases of a study
  • Background in pediatric and adolescent research including assent, consent, and age-appropriate protections
  • Prior experience supporting FDA or IVDR submissions
  • Multilingual capabilities are a plus
  • Proficiency with CTMS, EDC, and Microsoft Office Suite
  • Strong organizational skills with the ability to adapt quickly and manage competing priorities
  • Excellent communication and problem-solving skills
  • Ability to collaborate effectively in a global, cross-functional environment
  • Ability to travel up to 25 percent for site visits and team meetings
  • Must possess U.S. work authorization
  • Please Note: This is a customer-funded position. Continued employment is contingent upon the availability of customer funding.

The base salary range for this full-time position is $102,500.00 - $128,000.00. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.

#LI-JB1

What do we offer?

We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:

  • Medical, Dental, and Vision Insurance Options

  • Life and Disability Insurance  

  • Paid Time-Off

  • Parental Benefits

  • Compassionate Care Leave

  • 401k with Company Match

  • Employee Stock Purchase Plan

Learn more about Revvity’s benefits by visiting our Bswift page. Log-In instructions are provided towards the bottom of the Bswift page.

*For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information.

Revvity is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any characteristic or status protected by applicable federal, state, and/or local laws. If you are an applicant with a disability that requires reasonable accommodation to complete any part of the application process or are limited in the ability—or unable to use—the online application system and need an alternative method for applying, you may contact [email protected].

Top Skills

Ctms
Edc
Microsoft Office Suite
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The Company
Waltham, , Massachusetts
3,109 Employees
Year Founded: 2023

What We Do

At Revvity, “impossible” is inspiration, and ""can't be done"" is a call to action. Revvity provides health science solutions, technologies, expertise and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what’s possible in healthcare, with specialized focus areas in translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, informatics and more. With more than $3 billion in revenue and over 11,000 employees, Revvity serves customers across pharmaceutical and biotech, diagnostic labs, academia and governments. It is part of the S&P 500 index and has customers in more than 190 countries. Learn more at www.revvity.com

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