Human Subject Research Spec I
The Human Subject Research Specialist I is an entry-level clinical research coordinator responsible for supporting human subject research activities under supervision. Key duties include patient screening, enrollment in observational studies, maintaining study continuity including drug accountability, data entry into research databases, and ensuring compliance with Good Clinical Practice and federal regulations. This role supports clinical research protocols primarily in the Gastroenterology division and requires continuous professional development and adherence to institutional standards.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
What You’ll Do
You will work as an entry-level Human Subject Research Specialist I supporting clinical research studies under the supervision of the Principal Investigator (PI) and the research nurse coordinator. This role focuses on coordinating less-complex protocols, recruiting and screening participants, conducting study visits, maintaining study records, and ensuring study continuity and regulatory compliance.
- Coordinate participant screening, recruitment, and enrollment for observational and non-interventional studies (notably PHAR and ACTiPH)
- Review patient databases and charts to identify eligible participants and confirm inclusion criteria with the PI
- Conduct study visits and assessments (e.g., 6-minute walk, phlebotomy, EKG) and document findings
- Maintain drug and device accountability for study materials (oral and inhaled drugs where applicable)
- Maintain OnCore and study-specific research logs; perform data entry into study databases and electronic medical records per SOPs
- Assist with administrative study initiation tasks: distribution/explanation of protocol and recruitment materials to team members
- Track protocol changes, ensure training is updated, and implement required study modifications
- Follow Good Clinical Practice (GCP), federal/state regulations, sponsor rules, and institutional policies
- Participate in ongoing training and professional development activities (CITI, protocol training, research competencies)
- Perform other duties as assigned to support study operations
Minimum Qualifications
- Bachelor’s degree OR
- Associate’s degree plus completion of 6 months in a Human Subject Research Coordinator Trainee program OR
- Equivalent combination of education and experience
- Prior phlebotomy experience preferred
Skills & Certifications
- Familiarity with OnCore or similar clinical trial management systems preferred
- Basic experience with data entry, word processing, and data analysis software
- Knowledge of Good Clinical Practice (GCP) and federal/state human subjects regulations
- Strong attention to detail, organization, and ability to follow protocol-driven tasks
- Professional research coordinator certification (SoCRA or ACRP) preferred
- Current CITI training and other required certifications maintained as required by the project
Compensation & Schedule
- Compensation range (provided by client): $21.78 - $30.53 per hour
- Scheduled weekly hours: 40 (Full-time)
- Pay will be set within the posted range based on experience, qualifications, and internal equity considerations
Location
On-site in Rochester, NY. Job Location (full address provided by client): 601 Elmwood Ave, Rochester, NY 14642.
Additional Information
- This role reports to PI and research nurse coordinator and is part of a clinical research team in the Department of Medicine (Gastroenterology division).
- The Confidential Client is committed to an inclusive and welcoming workplace.
- Applicants may be required to maintain ongoing trainings and certifications relevant to human subject research.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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