Human Subject Research Specialist

001 University of Rochester; United States; On-site; USD 30,000 - 43,000; Full time

Job summary

The University of Rochester seeks a detail-oriented coordinator to support human subject research in the Psychology department. You will manage administrative tasks, help recruit and screen participants, and ensure adherence to study protocols and regulatory requirements.

You will review eligibility criteria, document adverse events, train staff on consent procedures, and liaise with sponsors and IRB to maintain compliant study documentation.

Qualifications

• Bachelor's degree required or Associate's degree with 6 months in the HR Research Coordinator Trainee program.
• Equivalent combination of education and experience accepted.
• Prior phlebotomy experience is preferred.

Responsibilities

• Coordinate administrative details required to initiate and conduct human subject research.
• Assist in recruitment and screening using site databases and office records.
• Participate in developing recruitment strategies.
• Conduct telephone interviews to screen potential study candidates.
• Review medical chart history to verify inclusion criteria before enrollment.
• Document adverse events and report to senior staff, PI, IRB, Sponsor, and others as required.
• Ensure data are collected and secured within approved parameters and procedures.
• Train staff on protocol details, inclusion/exclusion criteria, consent procedures, and CRFs.
• Liaise with Sponsor Monitor to provide data clarifications and scheduling of monitoring visits.

Skills

Word processing

Data analysis

Education

Bachelor's degree

Associate's degree + 6-month trainee program

Equivalent combination of education and experience

Job description

Job Location (Full Address)

775 Library Rd, Rochester, New York, United States of America, 14627

Opening

Worker Subtype: Regular Time Type: Time as Reported / Per Diem Scheduled Weekly Hours: As Scheduled Department: 210630 Psychology Work Shift: UR - Day (United States of America) Range: UR URG 106 H Compensation Range: $21.78 - $30.53

Responsibilities

• Coordinates the activities associated with human subject research.

ESSENTIAL FUNCTIONS

• Coordinates the administrative details required to initiate and conduct human subject research, including receiving, distributing, and explaining study information, such as protocol and human subject recruitment materials, to immediate team members and relevant others.
• Assists in human subject recruitment and screening activities, including reviewing study site patient databases and office records for patients that meet the protocol inclusion criteria.
• May participate in developing recruitment strategies.
• May conduct telephone interviews to screen potential study candidates.
• Reviews medical chart history with Principal Investigator to verify inclusion criteria are met before enrollment.
• Conducts visits to ensure research participant adherence with protocol requirements, such as taking of medications, proper use of device, and/or other interventional activities, to document adverse events and report to senior study staff, PI, Institutional Review Board (IRB), Sponsor, and/or any other required recipients or entities.
• Ensures all data are collected and secured within approved parameters and procedures.
• Ensures all immediate and extended team members understand and adhere to all aspects of all approved protocols, procedures, and standards for documentation and communication.
• Under general direction from the Principal Investigator (PI), trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, source documentation and case report form (CRFs) completion, and adverse event reporting.
• Reviews and documents the dispensing and returning of study materials, such as study drugs and devices.
• Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to.
• Acts as liaison with Sponsor’s Monitor to provide data clarifications, reviews study protocols, ensures thorough understanding and communication, responds to questions that arise during the study, communicates and documents adverse events as advised by the PI and ensures regulatory and other documents, such as consent forms and CRFs, are complete, accurate, and available for review.
• Communicates with Sponsor to clarify data queries to determine report format.
• Prepares for, participates in, and serves as liaison for scheduled Sponsor monitoring visits, such as pre-study inspection, initiation, on-going and close out visits.
• Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines and makes recommendations.
• Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines.
• Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies.
• Makes recommendations and implements changes as appropriate.
• Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree required or Associate's degree and completion of 6 months in the Human Subject Research Coordinator Trainee program required
• Or equivalent combination of education and experience
• Prior experience as a Phlebotomist preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Word processing and data analysis software preferred

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Located in western New York, Rochester is our namesake and our home. One of the world’s leading research universities, Rochester has a long tradition of breaking boundaries—always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better. If you’re looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals. At the University of Rochester, we are committed to fostering, cultivating, and preserving an inclusive and welcoming culture and are united by a strong commitment to be ever better—Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.