Human Subject Research Specialist II

University of Rochester•City of Rochester, NY

1d•Onsite

About The Position

The Human Sub Research Spec II will work within the Department of Neurology’s Cerebrovascular and Neurocognitive Research Group (CNRG). Research areas within CNRG involves different populations with cerebrovascular disease being the common denominator. Examples include but not limited to cerebral vascular disease associated with HIV infection or other inflammatory conditions, acute stroke and stroke recovery, and vascular dementia. . The research projects in the group include observational studies, clinical trials, and multi-center clinical research studies. The Study Coordinator II will have considerable latitude for independent judgment and coordinates all aspects of assigned human subject research studies. This role provides assistance to the Principal Investigator(s) and works as an integral part of the research team. This role mentors Human Subject Research Coordinator I(s) and supervises students as assigned.

Requirements

Bachelor’s degree required
2 years of experience in human subject research coordination required
Word processing and data analysis software required

Nice To Haves

Prior experience as Human Subject Research Coordinator I preferred or equivalent combination of education and experience
Experience as a Phlebotomist preferred
Professional Research Coordinator certification (SoCRA or ACRP) upon hire preferred

Responsibilities

Uses independent clinical judgement to recruitment, consent, enroll and retain study subjects across the CNRG portfolio of human subjects’ studies.
Develops, implements, and evaluates subject recruitment and retention strategies (i.e. display boards, pamphlets, patient referral program, and other in-office advertising initiatives).
Creates and modifies patient recruitment material as necessary.
Leads patient marketing/recruitment initiatives and community outreach initiatives such as participation in health fairs, community events and all activities to enhance department visibility and ability to attract potential patients for current and future clinical research trial participation.
Manages and updates registries used for subject recruitment
Coordinates schedules and conducts research study visits according to the protocol to support successful achievement of milestones, specific aims, and study objectives.
Performs study related procedures as outlined in the protocol and may include blood draw, brief physical exam, and cognitive function tests. Training will be provided where necessary to implement protocol’s procedures.
Coordinates and documents dispensing and returning of study drugs/materials.
Resolves questions and concerns received from study subjects, triaging to Principle Investigator as necessary.
Ensures patient clinical care resources are available to support conduct of human subject studies in accordance with protocol.
Coordinates and schedules appointments, and works with multidisciplinary teams for the provision of additional needed resources.
Inputs/regularly updates and reviews all patient information in the patient databases to ensure the most accurate databases possible including sponsor CRFs, Epic and OnCore as applicable.
Mentors and trains Neurology Study Coordinators (HSRC I) on activities related to conducting human subject research and provides back-up support across the CNRG team and department as needed.
Participates in annual performance evaluations/reviews for HSRC I.
Directs, understands, implements, and provides training on most recent study protocol (e.g., amended protocol), procedures, documentation, and use of study materials to subjects and team members as appropriate.
Ensures compliance, following up and communicating as needed.
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, modifies and maintains regulatory requirements for multiple research studies.
Manages IRB submissions to include study applications, amendments and continuing reviews.
Creates, modifies, organizes, and maintains study documentation for the regulatory file.
Ensures consistency and standardization of protocol activities across multiple sites.
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.
Serves as the liaison between cross-functional research team, additional research sites, research administration, study sponsors, and IRB to facilitate communication, resolves issues, and enhance collaboration.
Works with research administration team on pre-award and study start up documents providing expertise related to time studies and budget feasibility for study procedures, overall complexity and effort required for completing studies.
Reviews study progress, including communicating with research administrator and updating OnCore or other workbooks on enrollment, visits, and other study procedures completed to ensure maximum payment is received and expenses are monitored in accordance with budget.
Represents the University and Principle Investigator at study meetings as needed.
Schedules, prepares for, and attends study sponsor monitor meetings in accordance with protocol.
Develops and/or manages databases (e.g., EDC) 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 monthly study team meetings and provides updates on project status and changes in regulatory requirements as needed.
Other duties as assigned.