Senior Clinical Research Associate

Job Title: Sr. CRA – Transfusion Medicine / IVD

Duration: 1 year contract, potential of extension

Location: Remote with 75% travel

Client Overview:

Abbott is a global healthcare company focused on developing and delivering innovative technologies across

diagnostics, medical devices, nutrition, and pharmaceuticals. The organization operates in highly regulated

healthcare environments and supports products and solutions used by healthcare providers, laboratories, and

patients worldwide. Within Abbott, the Transfusion Medicine business supports diagnostic solutions used in

blood screening and transfusion-related testing, with a focus on ensuring the safety, accuracy, and reliability of

the global blood supply.

Job Description:

Abbott Transfusion Medicine is seeking experienced Clinical Research Associates to support the execution and

monitoring of a high-volume, instrument-based clinical study. This role will serve as a key liaison between

Abbott and participating clinical sites, providing independent monitoring and ensuring study activities are

conducted in accordance with the clinical protocol, applicable regulations, Good Clinical Practice, and Abbott

procedures.

Unlike a traditional CRA position, this role requires a strong combination of clinical research monitoring

experience and hands-on clinical laboratory expertise. The CRA must be comfortable evaluating not only

clinical site operations and study documentation, but also laboratory testing activities involving diagnostic

instrumentation, sample processing, instrument runs, and associated testing workflows.

Each CRA is expected to support approximately 1–2 clinical sites. While the number of assigned sites is limited,

the study is expected to involve exceptionally high testing and sample volumes, requiring strong attention to

detail, technical understanding, organization, and the ability to independently manage complex site activity.

Responsibilities:

• Independently manage and monitor approximately 1-2 high-volume clinical study sites, serving as a

primary point of contact between Abbott and assigned sites.

• Conduct clinical monitoring activities in accordance with study protocols, monitoring plans, GCP,

applicable regulatory requirements, and Abbott procedures.

• Monitor site performance, study conduct, protocol adherence, documentation completeness, and overall

data quality.

• Review study documentation and clinical data for accuracy, completeness, consistency, and appropriate

source support.

• Maintain regular communication with investigators, laboratory personnel, study coordinators, and other

site stakeholders to facilitate successful study execution.

• Monitor and understand laboratory testing workflows, including sample receipt and processing,

instrument operation, testing activities, instrument runs, and associated documentation.

• Evaluate site compliance with study-specific procedures related to diagnostic instrumentation and

laboratory testing.

• Identify protocol deviations, documentation deficiencies, data discrepancies, instrument/testing

concerns, and other study risks and escalate appropriately.

• Follow up with sites to drive timely resolution of outstanding documentation, data, testing, or

operational issues.

• Partner closely with Abbott Clinical, Medical, Project Management, and other cross-functional

stakeholders to communicate site status, risks, and study progress.• Maintain complete, accurate, and timely monitoring reports and other required clinical documentation.

• Support site initiation, ongoing monitoring, and closeout activities as required throughout the study

lifecycle.

• Manage significant testing volumes that may include thousands of samples or tests at individual study

sites.

• Participate in periodic in-person team meetings at Abbott's Conway Park/Lake County, Illinois location,

currently anticipated approximately twice per month.

• Travel to assigned clinical sites as study activity increases, with travel anticipated to reach

approximately 60-75% during peak study periods.

• Primarily support U.S.-based clinical sites, with potential opportunities to support European study

activity based on project needs and individual availability.

Highly Preferred:

• Previous experience as a Medical Technologist (MT), Medical Laboratory Scientist (MLS), or Clinical

Laboratory Scientist (CLS).

• Clinical laboratory experience within blood banking, transfusion medicine, blood screening, or related

disciplines.

• Experience with molecular diagnostics, PCR, or other molecular testing instrumentation.

• Previous CRA experience supporting IVD, medical device, diagnostic instrumentation, blood screening,

or instrument-based clinical studies.

• Experience working for a diagnostics, medical device, or life sciences manufacturer in a clinical

research capacity.

• ASCP certification or equivalent laboratory certification.

• Illinois or Midwest-based, with the ability to periodically work onsite with the Abbott Transfusion

Clinical team.

• Flexibility to support international clinical sites, including potential extended European site visits, as

needed

Qualifications, Education/Certification(s)/License(s):

• Bachelor's degree in Medical Laboratory Science, Clinical Laboratory Science, Molecular Biology,

Biology, Life Sciences, or a related scientific discipline.

• Previous CRA experience with independent, sponsor-side clinical site monitoring responsibilities.

• Prior professional experience within a clinical laboratory, medical technology, diagnostics, or similarly

technical laboratory environment.

• Demonstrated experience working with laboratory instrumentation and instrument-based testing

workflows.

• Working knowledge of clinical research regulations, Good Clinical Practice (GCP), clinical monitoring

practices, and clinical study documentation.

• Ability to independently monitor both traditional clinical study activities and laboratory/instrument-

related study activities.

• Strong understanding of sample handling, sample processing, laboratory testing, and associated

documentation requirements.

• Ability to manage high-volume, detail-intensive clinical study activity while maintaining documentation

and data quality.• Strong customer-facing communication skills with the confidence and professionalism to work directly

with investigators, laboratory personnel, study coordinators, and Abbott leadership.

• Ability to work independently while collaborating effectively within a small, highly integrated clinical

team.