Sr. Clinical Research Associate

Position: Senior Clinical Research Associate (Sr. CRA) – Transfusion Medicine / IVD

Location: Remote with around 75% travel

Schedule: Monday–Friday, approximately 8:00 AM–5:00 PM CT

Contract Length: 12 months with significant travel

Travel: Expected to increase to approximately 60–75% as the study ramps up

Position Overview:

Our client is seeking experienced Senior Clinical Research Associates to support a high-profile, high-volume clinical study within its Transfusion Medicine group.

This is a unique CRA opportunity that combines traditional independent clinical site monitoring with hands-on knowledge of clinical laboratory operations, diagnostic instrumentation, sample processing, and testing workflows. The ideal candidate will have experience working as a Medical Technologist, Medical Laboratory Scientist, Clinical Laboratory Scientist, or in a similar laboratory environment before transitioning into clinical research and CRA responsibilities.

Each CRA will be responsible for approximately 1–2 clinical study sites. While the site load is smaller than a traditional CRA position, these are highly complex sites with significant testing volumes that may include thousands of samples or tests per site.

The CRA will serve as a primary liaison between the sponsor and participating clinical sites, ensuring study activities are conducted according to the clinical protocol, Good Clinical Practice, applicable regulatory requirements, and established study procedures.

Key Responsibilities:

• Independently manage and monitor approximately 1–2 high-volume clinical study sites.
• Serve as a primary point of contact between the sponsor and assigned clinical sites.
• Conduct independent site initiation, interim monitoring, ongoing monitoring, and closeout activities as required.
• Monitor site performance, study conduct, protocol adherence, documentation completeness, and overall data quality.
• Review clinical data and study documentation for accuracy, completeness, consistency, and appropriate source support.
• Maintain regular communication with investigators, laboratory personnel, study coordinators, and other site stakeholders.
• Monitor laboratory testing workflows, including sample receipt, sample processing, instrument operation, testing activities, instrument runs, and associated documentation.
• Evaluate site compliance with study-specific procedures involving diagnostic instrumentation and laboratory testing.
• Identify and escalate protocol deviations, documentation deficiencies, data discrepancies, instrument/testing concerns, and other study risks.
• Follow up with sites to drive timely resolution of outstanding documentation, data, testing, or operational issues.
• Partner with Clinical, Medical, Project Management, and other cross-functional stakeholders to communicate site status, study progress, and potential risks.
• Maintain complete, accurate, and timely monitoring reports and required clinical documentation.
• Successfully manage highly detail-oriented study activity that may involve thousands of samples or tests at individual sites.

Ideal Background:

This is not a traditional pharmaceutical CRA profile. The strongest candidates will bring a combination of independent clinical monitoring experience and hands-on clinical laboratory expertise.

The ideal candidate may have started their career within a medical technology, clinical laboratory, blood bank, blood screening, transfusion medicine, or molecular diagnostics environment before transitioning into clinical research.

Candidates should be comfortable walking into a clinical laboratory and communicating directly with Medical Technologists and laboratory personnel about their testing processes, instrumentation, sample workflows, and study-related issues.

Required Qualifications:

• Bachelor's degree in Medical Laboratory Science, Clinical Laboratory Science, Molecular Biology, Biology, Life Sciences, or a related scientific discipline.
• Previous CRA experience involving independent clinical site monitoring responsibilities.
• Previous professional experience within a clinical laboratory, medical technology, diagnostics, or similarly technical laboratory environment.
• Experience working directly with laboratory instrumentation and instrument-based testing workflows.
• Working knowledge of Good Clinical Practice (GCP), clinical monitoring practices, clinical research regulations, and clinical study documentation.
• Understanding of sample handling, sample processing, laboratory testing, and associated documentation requirements.
• Ability to independently monitor traditional clinical study activities as well as laboratory and instrument-related study activities.
• Ability to manage high-volume, detail-intensive clinical study activity while maintaining strong documentation and data quality.
• Strong site-facing and customer-facing communication skills.
• Confidence communicating directly with investigators, study coordinators, Medical Technologists, laboratory personnel, and other stakeholders.

Highly Preferred Experience:

• Previous experience as a Medical Technologist (MT), Medical Laboratory Scientist (MLS), or Clinical Laboratory Scientist (CLS).
• Blood banking, transfusion medicine, blood screening, donor testing, or related laboratory experience.
• Molecular diagnostics or molecular testing experience.
• Experience with PCR, nucleic acid testing (NAT/NAAT), or other molecular diagnostic platforms.
• Experience supporting IVD, medical device, diagnostic instrumentation, blood screening, or instrument-based clinical studies.
• Previous clinical research experience within a diagnostics, medical device, or life sciences organization.
• ASCP certification or equivalent laboratory certification.
• Experience monitoring actual laboratory testing or instrument runs in addition to traditional clinical documentation.
• Experience identifying and resolving issues involving sample handling, laboratory workflows, instrumentation, or testing activities.

Location & Travel Expectations:

This position will be remote when not traveling or attending team meetings. Candidates located throughout the Midwest, including Illinois, Wisconsin, and Indiana, are strongly encouraged to apply.

The clinical team periodically meets in person at its Lake County, Illinois office, currently anticipated to be approximately twice per month.

Travel will increase as the clinical study ramps up and is anticipated to reach approximately 60–75% during peak study periods. Travel will primarily be to U.S.-based clinical sites.

What Makes This Opportunity Unique:

This position is an excellent fit for someone who enjoys the site-facing and relationship-building responsibilities of a CRA but also wants to remain closely connected to the technical laboratory side of clinical research.

Rather than focusing exclusively on clinical documentation, this CRA will have visibility into the actual testing environment, including diagnostic instrumentation, molecular testing, sample processing, instrument runs, and laboratory workflows. The combination of clinical monitoring and laboratory expertise will be critical to successfully supporting these complex, high-volume study sites.