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Human Subject Research Specialist I

Confidential ClientEducation
Entry LevelFull-timeOn-Site$57,507
Rochester, New York
A Day Ago

The Human Subject Research Specialist I at Confidential Client supports clinical research studies within the Transplant Institute by coordinating participant recruitment, data collection, and regulatory compliance under supervision. This entry-level role involves managing study documentation, assisting with protocol implementation, and ensuring adherence to institutional and federal research standards to facilitate successful clinical trials.

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Description

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.


Overview

Confidential Client is seeking an entry-level Human Subject Research Specialist I to support clinical research activities within their Transplant Institute and Surgery Research infrastructure. This role assists Principal Investigators and senior research staff with participant recruitment, study visits, data collection, regulatory documentation, and general study coordination while receiving ongoing training and mentorship.


Compensation

  • Hourly range: $21.78 – $30.53 per hour.
  • Estimated annual midpoint (for reference): ~$57,507 per year (actual salary will be set based on experience, education, and internal equity).

What You’ll Do

  • Coordinate participant recruitment, screening, enrollment, and retention activities for assigned clinical research studies under supervision.
  • Review recruitment sources, medical records, and study databases to identify potential participants who meet protocol eligibility criteria.
  • Conduct participant outreach, schedule study visits, and assist with informed consent and study-related procedures in accordance with approved protocols.
  • Support completion of study visits and perform research procedures according to protocol, departmental SOPs, and Good Clinical Practice (GCP).
  • Collect, enter, maintain, and verify study data and source documentation to ensure completeness, accuracy, confidentiality, and integrity.
  • Process, prepare, and ship study samples following sponsor and protocol requirements.
  • Maintain research participant records, regulatory binders, consent forms, case report forms, and study correspondence.
  • Document protocol deviations, adverse events, and reportable findings to senior research staff and the Principal Investigator (PI) per established procedures.
  • Assist with sponsor monitoring visits, internal audits, protocol amendments, and resolution of data queries.
  • Participate in required training, maintain certifications (e.g., GCP), and add studies/subjects to institutional systems (e.g., OnCore) as directed.
  • Perform other duties as assigned and participate in professional development activities.

Required 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.
  • Ability to follow protocol procedures, maintain accurate records, and communicate effectively with participants and the study team.
  • Willingness to learn regulatory requirements and Good Clinical Practice principles.

Preferred Qualifications

  • Prior experience as a phlebotomist preferred.
  • Familiarity with word processing and basic data analysis software.
  • Previous exposure to clinical research settings or study coordination is a plus.

Working Conditions & Additional Information

  • Full-time position (40 hours/week), Day shift.
  • Role includes in-person participant interactions and may require travel between clinical sites.
  • This is an entry-level role designed for development; ongoing mentorship and training will be provided.
  • Confidential Client is committed to an inclusive workplace and follows all applicable federal, state, and local employment laws.

Key Skills & Keywords

  • Clinical research coordination
  • Participant recruitment & retention
  • Good Clinical Practice (GCP)
  • Informed consent processes
  • Study documentation & regulatory compliance
  • Data entry & source documentation
  • Phlebotomy (preferred)

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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