Human Subject Research Specialist

University of Rochester•City of Rochester, NY

1d•Onsite

About The Position

The University of Rochester is seeking a Human Subject Research Specialist (HSRS I) to coordinate clinical research projects involving patients with muscular dystrophy, specifically myotonic dystrophy. These projects include clinical trials evaluating genetic therapies and observational studies utilizing a remote research platform. The HSRS I will assist in enhancing and expanding this platform, working as an integral part of the research team. This role involves assisting the principal investigator and project manager, and communicating with study participants. The University of Rochester is committed to fostering an inclusive and welcoming culture, guided by the values of equity, leadership, integrity, openness, respect, and accountability.

Requirements

Bachelor’s degree required Or Associate's degree and completion of 6 months in the Human Subject Research Coordinator Trainee program Or equivalent combination of education and experience
Word processing and data analysis software preferred
Prior experience as a Phlebotomist preferred
REDCAP experience preferred
CLASP, SOCRA, or ACRP preferred

Responsibilities

Coordinates the administrative details required to initiate and conduct human subject research, including receiving, distributing, and explaining study information.
Assists in human subject recruitment for clinical trials and remote research, including screening activities and reviewing patient databases.
May participate in developing recruitment strategies and conduct telephone interviews to screen potential study candidates.
Reviews medical chart history with the Principal Investigator to verify inclusion criteria are met before enrollment.
Assists in remote research platform management, including monitoring equipment, cleaning, preparing for shipment, and monitoring remote patient blood sample collection.
Assists with data management and data integrity, including monitoring and assisting with data entry for clinical trials and remote research.
Assists with scoring of video-captured functional assessments using SOPs.
Conducts visits to ensure research participant adherence with protocol requirements, such as assisting in consenting, taking of medications, proper use of device, and/or other interventional activities.
Documents adverse events and reports to senior study staff, PI, Institutional Review Board (IRB), Sponsor, and/or any other required recipients or entities.
Ensures all data is collected and secured within approved parameters and procedures.
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.
Manages the regulatory details for assigned research studies, including preparing and maintaining regulatory and study documentation.
Manages and submits amendments and continuing reviews for IRB approval.
Ensures all regulatory requirements are met and documented.
Provides data clarifications, reviews study protocols, ensures thorough understanding and communication, responds to questions, communicates and documents adverse events, and ensures regulatory and other documents are complete, accurate, and available for review.
Communicates with Sponsor to clarify data queries and determine report format.
Prepares for, participates in, and serves as liaison for scheduled Sponsor monitoring visits.
Performs other duties as assigned.