Sr Clinical Research Associate
About The Position
Join a collaborative and mission-driven Clinical team dedicated to advancing innovative technologies that improve lives. As a Sr. Clinical Research Associate (CRA), you will play a hands-on role in bringing clinical studies to life—from protocol and document development to patient recruitment, consent, screening, and study visit execution. This team thrives on curiosity, precision, and creative problem-solving, and values individuals who bring both structure and flexibility to a fast-paced research environment. If you enjoy balancing critical thinking with meaningful patient interaction and want to directly contribute to high-impact clinical programs, this is a team where your work truly makes a difference. As a Sr CRA, you will support execution of clinical studies to support product development and validation while building strong relationships with clinical trial sites. You will collaborate cross-functionally to ensure on-time monitoring, audit-readiness both at sponsor and sites, and will contribute to study reports and regulatory submission deliverables. You will collaborate effectively with peers and leadership across departments and professionally interact/build relationships with Investigators and site staff, Institutional Review Boards (IRBs), and key opinion leaders. You will develop study documentation, perform site selection/qualification, train and support sites in study procedures, monitor study compliance, study closeout, and other activities related to study operations. You will coordinate with monitors and data management to ensure data quality and timeliness. You will contribute to process improvements across all aspects of clinical study operations.
Requirements
- Ability and judgement to work under minimal supervision to plan and execute site study operations, including on-site and remote training & support, requesting and tracking supplies, documentation, training sites and fellow team members, and generating progress reports.
- Ability to communicate effectively with site staff, including Principal Investigators, and internal study team members.
- Skill and experience at working cross-functionally to achieve goals.
- Strong Good Clinical Practice (GCP) and clinical study background, including experience as a CRA; experience in the medical device industry and/or with diabetes is a plus.
- Ability to work on multiple studies concurrently and to work with monitors successfully to reduce overall time from last participant on study to database lock while improving site compliance.
- Experience with using electronic data capture systems (EDC), Clinical Trial Management Systems (CTMS), and electronic trial master files (eTMF).
Nice To Haves
- Experience in the medical device industry and/or with diabetes is a plus.
- Preferred experience with Continuous Glucose Monitoring (CGM) Systems.
- Preferred experience in diabetes clinical trials involving insulin therapies, insulin pumps, or digital health technologies.
Responsibilities
- Support execution of clinical studies to support product development and validation while building strong relationships with clinical trial sites.
- Collaborate cross-functionally to ensure on-time monitoring, audit-readiness both at sponsor and sites, and will contribute to study reports and regulatory submission deliverables.
- Collaborate effectively with peers and leadership across departments and professionally interact/build relationships with Investigators and site staff, Institutional Review Boards (IRBs), and key opinion leaders.
- Develop study documentation, perform site selection/qualification, train and support sites in study procedures, monitor study compliance, study closeout, and other activities related to study operations.
- Coordinate with monitors and data management to ensure data quality and timeliness.
- Contribute to process improvements across all aspects of clinical study operations.
- Plan and execute site study operations, including on-site and remote training & support, requesting and tracking supplies, documentation, training sites and fellow team members, and generating progress reports.
- Communicate effectively with site staff, including Principal Investigators, and internal study team members.
- Work cross-functionally to achieve goals.
- Work on multiple studies concurrently and to work with monitors successfully to reduce overall time from last participant on study to database lock while improving site compliance.
Benefits
- A full and comprehensive benefits program.
- Growth opportunities on a global scale.
- Access to career development through in-house learning programs and/or qualified tuition reimbursement.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
