BioLegend, Inc.
Senior Clinical Research Associate (Project Lead)
BioLegend, Inc., Oklahoma City, Oklahoma, United States
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 elevate 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
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.
#J-18808-Ljbffr
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 elevate 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
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.
#J-18808-Ljbffr