University of Rochester Human Subject Res Coord I - 222726 in Rochester, New York
Human Subject Res Coord I
School of Medicine & Dentistry
Full Time 40 hours Grade 051 Pediatrics M&D Inf Diseases
8 AM-5 PM; POSS WKNDS/HOL/EVENINGS
A position in Pediatric Infectious Diseases Division in the Medical Center to conduct pediatric clinical and translational studies. In particular, this individual will be responsible for recruitment and administrative responsibilities under the direction of the Principal Investigator. This individual will screen and recruit potential study candidates that meet inclusion criteria and perform interviews, data/specimen collection (including phlebotomy) medical chart reviews, and ensure all data are collected and secured within approved parameters and procedures. This person will conduct visits to ensure research participant adherence with protocol requirements such as taking of medications, proper use of device, and/or other interventional activities. This individual will also document adverse events and report to the Principal Investigator (PI), Institutional Review Board (IRB), Sponsor and/or any other required recipients or entities.
The individual will keep current with all federal, state, sponsor and institutional policies and laws, standard operating procedures and guidelines, and make recommendations regarding ways to improve study procedures. Demonstrate accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. Keep current with industry standards, best practices, act as liaison with Sponsor’s Monitor and ensure data is up to date and accurate, providing data clarifications as necessary. He/she will review study protocols, ensure thorough understanding and communication, respond to questions that arise during the study, communicate and document adverse events as advised by the Principal Investigator, and ensure regulatory and other documents (such as consent forms and CRFs) are complete, accurate and available for review. Communicate with Sponsor to clarify data queries to determine report format. Prepares for, participates in and serves as liaison for scheduled Sponsor monitoring visits (i.e., pre-study inspection, initiation, on-going and close out visits).
He/she must work well as part of a team, be able to complete project tasks independently as requested, be comfortable with a variety of data bases, and at all times demonstrate the ability to interact in a professional and positive manner in both verbal and written communications.
This position requires the ability to work independently. The candidate must possess strong interpersonal skills in order to communicate with families, pediatricians, hospital staff, research staff and sponsors. The applicant must be willing to develop the logistics of and participate in subject enrollment, be persistent and flexible in assuring on-going subject cooperation/ compliance, and possess excellent data collection and organizational skills. Ability to accurately extract and record data required. Computer skills required. Interfacing with sponsors and study monitors as well as maintaining all regulatory requirements is required. The position may require travel to private medical offices or homes in the Rochester area to perform subject enrollment, vaccine record verification and medical chart abstraction. Travel to investigator meetings may also be necessary. Candidate must become Human Subjects and Good Clinical Practice certified via the Citi program within the first week of employment.
Associates degree and 1 year of experience in human subject research coordination; or equivalent combination of education and experience. Knowledge of word processing and data analysis software preferred. Experience with specimen collection, specimen labeling, human subjects review, and coordination preferred. Expertise with Microsoft office including Excel required. Knowledge of e-Record preferred.
Dr. Mary Caserta, Dr. Jennifer Nayak
Computer; fax machine, scanner, copier, printer, telephone
NOTE: This document describes typical duties and responsibilities and is not intended to limit management from assigning other work as required.
Responsibilities / Standards
% of Time
Screening, recruitment, and monitoring of study subjects.
Screen eligible patients to make sure they meet enrollment criteria. Explain study to parent and obtain informed consent.
Conduct study visits with subjects and ensure patient compliance with project protocol.
Document and report adverse events to investigators and IRB or other agencies as required.
Assist in developing recruitment strategies and monitoring target enrollment numbers. Responsible for securing all data following study protocols and HIPAA compliance.
Interviews with families as required by protocol.
Collection (including phlebotomy), labeling, and coordination of study specimens to be delivered to the laboratory; insure labeling is sequential and interfaces with lab labeling system.
Medical chart review and information abstraction/recording, phone communications with families/pediatricians/staff, fax or mail letters to recruit subjects or communicate with previously enrolled subjects.
Data entry and integrity checks: enter data into web based database and respond to data queries as they arise.
Completion of source documents: CRFs, vaccine verifications, and 2-3 follow up phone calls for study cohort.
Responsibilities / Standards
% of Time
Assist the PI in drafting or reviewing research protocols and budgets, consent documents, and other study documents and upload documents to the IRB and study sponsors (eg NIH, pharmaceutical companies)
Maintain all required regulatory and training documentation for research studies (IRB, DMID)
Research Team Collaboration
Attend team meetings as needed and interact with study team to ensure regulatory and other documents are complete and on time.
Reports on status of studies, identifying issues and proposing resolutions
Position also rated according to attendance record.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled