Human Subjects Research Coordinator- II

The University of Rochester is hiring a Human Subjects Research Coordinator II for its Ob/Gyn research department. The role coordinates day-to-day activities for a clinical study involving pregnant women, including participant recruitment and visits, specimen and data collection, study administration, and coordination with investigators and research partners.

Responsibilities

• This is a full-time position (40 hrs/wk) in Ob/Gyn to conduct clinical research study among pregnant women
• In particular this individual will be responsible for recruitment and administrative responsibilities for one NIH funded study under the direction of the Principal Investigator
• This individual will screen and recruit potential study candidates and perform interviews, data/specimen collection, chart reviews, and data entry
• Oversee and coordinate human subject research activities for UofR Study site. Develops and implements and evaluates recruitment strategies and study management systems. Participates in the development of consent forms and study design policies. Participates in the review and upkeep of study-specific procedure manuals and documents. Schedule and conduct study visits, consenting participants and explaining study protocols to ensure patient compliance. Works independently with input from the PI. Is responsible for subject tracking, administering the study vitamin D on the first study day, drawing blood, processing biological sampling, ensuring form completion, and adherence to protocol
• Assist in developing protocol with PI, recruitment strategies, and monitors target enrollment numbers. Inform Cornell study team when subjects complete study and need to be reimbursed. Interface with PI at Cornell to update on enrollment status and any issues that arise during the study
• Study administration, participates in advertising material development, and coordination of study with PI. Is solely responsible for the day-to-day operations of the study and must use independent judgment. Represents study team to maintain positive communication and relationships among the PIs, research staff and sponsoring and regulatory agencies
• Completes interviews and phone calls with subjects as required by protocol
• Completion of source documents: CRFs, follow-up phone calls, and subject mailings
• Provide collection, labeling, and coordination of study specimens to be delivered to the core laboratory; ensure labeling is correct and coordinate sample shipments to Cornell
• Perform chart reviews and information abstraction/recording, phone communications with subjects, fax/mail as necessary as pertains to enrolled subjects at your site
• Perform data entry and integrity checks; enter data into web-based database and respond to sponsor data queries as they arise
• Interface with study monitors to answer any questions and keep complete regulatory and subject documentation
• Coordinate with the PI, the sponsor, and the data monitors to ensure regulatory and other documents are complete and on time
• Attend team meetings and conference calls as needed

Preferred

• Experience as a Phlebotomist preferred
• Knowledge of Microsoft Office and Windows software preferred
• Experience with data entry or management preferred
• SOCRA - Certification in Clinical Research upon hire preferred
• Association of Clinical Research Professionals (ACRP) upon hire preferred
• Phlebotomy experience
• Microsoft Office
• Windows software
• Data entry
• Data management
• SOCRA clinical research certification
• ACRP certification

Company

• Private research university offering bachelor's, master's, and doctoral degrees.
• Rochester, New York, USA
• https://www.rochester.edu/
• Founded in 1850
• 10001+ employees

Qualifications

• Must work well as part of a team
• be able to complete project tasks independently as requested
• be comfortable with a variety of databases
• be detail-oriented
• the ability to interact in a professional and positive manner in both verbal and written communications
• Bachelor's degree and 2 years of experience in human subject research coordination required
• Or equivalent combination of education and experience
• Word processing and data analysis software required
• Be able to complete project tasks independently as requested
• Be comfortable with a variety of databases
• Be detail-oriented
• The ability to interact in a professional and positive manner in both verbal and written communications
• Experience as a Phlebotomist preferred
• Knowledge of Microsoft Office and Windows software preferred
• Experience with data entry or management preferred
• SOCRA - Certification in Clinical Research upon hire preferred
• Association of Clinical Research Professionals (ACRP) upon hire preferred

Required skills

• ACRP Clinical Research Certification, Human Subjects Research Coordination, Phlebotomy, SOCRA Clinical Research Certification, Windows

Preferred skills

• (106), (126), (130), (233), *2026, 2021, 2022, 2023, 2024, 2025, 3.9, 48, Accounting and Finance, Creatives and Design, Customer Service and Support, Data Powered by, Distribution of Different Job Fields Receiving Sponsorship, Education and Training, Engineering and Development, Experience as a Phlebotomist preferred, Experience with data entry or management preferred, Glassdoor, H1B Sponsorship, Human Resources, Knowledge of Microsoft Office and Windows software preferred, Management and Executive, Represents job field similar to this job, Rochester, New York, USA, Trends of Total Sponsorships, https://www.rochester.edu/

Experience

• 2+ years