Clinical Research Associate I

Required Qualifications (as evidenced by an attached resume):

Bachelor's degree (foreign equivalent or higher) in health-related life science, or social science field. Two (2) years full-time clinical and/or laboratory research experience.

Preferred Qualifications:

CITI certification (or willingness to complete promptly upon hire). Prior experience in clinical research or a surgical/procedural specialty. Prior laboratory management or biorepository/specimen inventory experience. Familiarity with IRB protocols, informed consent, and GCP. Experience with biospecimen handling and/or using LIMS software.

Brief Description of Duties:

Supports the day-to-day operations of clinical research studies through patient recruitment and consent, biospecimen collection and processing, laboratory and biorepository management, data entry, regulatory support, and coordination with clinical, surgical, and research teams. Ensures compliance with IRB, HIPAA, Good Clinical Practice (GCP), and institutional policies while facilitating the successful execution of multiple research protocols.

Duties Patient Recruitment and Consent

• Screen patient records and operative schedules to identify eligible research participants across concurrent IRB-approved protocols
• Approach, educate, and consent eligible patients under investigator supervision per IRB/GCP standards
• Maintain recruitment logs, eligibility records, and manage participant communications: Clinic-Based Specimen Acquisition, Satellite Sites
• Travel independently to satellite clinic sites, typically twice weekly, to collect urine specimens from enrolled participants; a personal vehicle is required
• Coordinate with satellite clinic staff and physicians to identify patients approaching scheduled specimen collection visits and integrate collection into clinic flow
• Transport specimens from satellite sites back to the central laboratory promptly, consistent with specimen stability and processing timelines
• Maintain chain-of-custody documentation for specimens collected off-site Operating Room Coordination and Specimen Acquisition - Essential
• Coordinate with surgical schedulers, OR staff, and surgeons to flag cases with specimen collection needs
• Be present at or on-call for surgical cases to facilitate timely specimen acquisition
• Coordinate with Pathology and maintain chain-of-custody documentation

Specimen Pipeline and Biorepository Management

• Process biospecimens (urine, blood, tissue) per SOPs, including centrifugation, aliquoting, and labeling
• Maintain and organize the laboratory biorepository and freezer inventory with accurate location tracking
• Monitor storage conditions, ensure biosafety compliance, and coordinate specimen requests across studies

Laboratory Operations Management

• Manage day-to-day lab operations: ordering/tracking supplies, reagents, and equipment
• Maintain SOPs, coordinate equipment maintenance/calibration, and support biosafety/regulatory compliance
• Help onboard and orient new lab members, trainees, and volunteers

Data Entry and Records Management

• Enter participant data into REDCap or designated databases; maintain HIPAA/IRB-compliant records
• Assist with regulatory documents, IRB amendments/renewals, and protocol deviation/AE reporting

Program Coordination

• Serve as operational point of contact for active protocols; attend lab/departmental meetings:

Other Duties as Assigned

Special Notes:

The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding. FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption. Must be able to travel between multiple locations For this position, we are unable to sponsor candidates for work visas.

Resume/CV and cover letter should be included with the online application.

Stony Brook University is committed to excellence in the creation of an inclusive learning and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status, and all other protected classes under federal or state laws.

Stony Brook University is dedicated to providing equal employment opportunities to all applicants, including individuals with disabilities. If you require a reasonable accommodation to participate in the application, interview, or hiring process, please request one by contacting oea_ada@stonybrook.edu. We will consider accommodation requests in compliance with applicable laws. This process is independent and does not require any voluntary self-identification of disability status. Please include the position title and position number (if known) in your message

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The starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU’s good faith and reasonable estimate of the range of possible compensation at the time of posting.