Human Subject Research Specialist II

University of Rochester•Rochester, NY

1d•$25 - $35•Onsite

About The Position

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive. This role coordinates clinical research projects involving patients with muscular dystrophy, specifically myotonic dystrophy. These projects include clinical trials evaluating genetic therapies and observational studies, leveraging a remote research platform. The Study Coordinator will assist in enhancing and expanding this platform. This position works as an integral part of the research team, assisting the principal investigator, communicating with study participants, and the broader DM community. This role mentors Human Subject Research Coordinator I(s) and supervises students as assigned.

Requirements

Bachelor's degree and 2 years of experience in human subject research coordination required
Equivalent combination of education and experience
Word processing and data analysis software required

Nice To Haves

If applicable, department specific experience required
Experience as a Phlebotomist preferred
Experience as Human Subject Research Coordinator I preferred
Expertise with REDCap preferred
SOCRA - Certification In Clinical Research upon hire preferred
Association of Clinical Research Professionals (ACRP) upon hire preferred

Responsibilities

Coordinates, schedules, and conducts research study visits in accordance with the protocol to support the successful achievement of milestones, specific aims, and study objectives.
Performs study-related procedures as outlined in the protocol. Training will be provided where necessary to implement the protocol’s procedures.
Resolves questions and concerns received from study subjects, triaging to the Principal Investigator as necessary.
Coordinates and schedules appointments and works with multidisciplinary teams.
Performs testing, including timed mobility tests and questionnaire administration and creates shipments of biological materials.
Assists with study start-up activities including budget development, ancillary approvals, and the creation of study materials.
Monitors changes in patients’ health and performs safety reporting and follow-up.
Maintains patient charts and facilitates study monitoring with sponsors and contract research organizations.
Assist in remote research platform management. This includes monitoring equipment sent to and from study participants, cleaning and preparing equipment for shipment, and facilitating remote patient blood sample collection.
Uses independent clinical judgement to recruit, consent, enroll, and retain study subjects across human subjects’ studies.
Develops, implements, and evaluates subject recruitment and retention strategies.
Creates and modifies patient recruitment material as necessary.
Leads patient recruitment initiatives and community outreach initiatives, such as participation in patient conferences.
Manages and updates registries used for subject recruitment.
Ensures adherence to regulatory requirements for research studies.
Manages IRB submissions to include study applications, amendments and continuing reviews.
Creates, modifies, organizes, and maintains study documentation for the regulatory file.
Responsible for monitoring compliance with all regulatory and institutional policies, and takes corrective action on issues identified.
Trains on federal, state, sponsor, and/or institutional regulations, policies, and practices related to human subject research.
Mentors and trains NMD Study Coordinators (HSRC I) on activities related to conducting human subject research and provides back-up support across the team as needed.
Directs, understands, implements, and provides training on updates to the study protocol, procedures, documentation, and use of study materials to subjects and team members as appropriate.
Ensures compliance by monitoring progress with training completion and implementation.
Keeps current with study-specific training, including understanding specific details of study protocol, all relevant sponsor and institutional policies, standard operating procedures, and guidelines.
Troubleshoots and resolves operational issues related to studies.
Develops and/or manages databases for research studies.
Ensures data is entered in a timely manner and database(s) is up-to-date.
Exports research data used for analysis and preparation of presentations, abstracts, and publications.
Develops, implements, and monitors systems and methods to ensure data integrity.
Assist in chart abstraction for the maintenance of patient databases.
Demonstrates accountability for continuous learning related to clinical research.
Attends training sessions and other educational opportunities related to clinical research in order to keep current with Good Clinical Practice guidelines, federal and state polices and laws, institutional certifications, industry standards and best practices, and trends in relevant therapeutic areas.
Participates in weekly study team meetings and provides updates on project status and changes in regulatory requirements as needed.
Other duties as assigned