Sr Human Subject Research Specialist

University of Rochester•City of Rochester, NY

1d•Hybrid

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 position serves as a study manager at a senior professional level for the Principal Investigator, Dr. Robert Block’s Preventive Cardiology Research program. The role involves planning, directing, monitoring, and coordinating all phases of human subject and clinical research. It requires providing professional direction and coordination within the project and maintaining a working knowledge of the area(s) of expertise by reviewing research literature, abstracts, attending pertinent meetings and seminars. The specialist will manage, design, implement, and evaluate study changes. Excellent communication and solid computer skills are required, including proficiency in word processing, database utilities, internet navigation, and email programs. The ability to interact professionally with staff at all levels, work with study subjects and the research team to complete research protocols, and coordinate multiple activities as part of a team is essential. Excellent knowledge regarding human subjects’ research requirements/regulations is mandatory. This position includes travel to medical offices and other potential study sites but is otherwise expected to work onsite.

Requirements

Bachelor’s degree required
5 years of experience in human subject research coordination required or equivalent combination of education and experience required
Solid computer skills with knowledge of word processing, database utilities, internet navigation, and email programs required.
At all times must demonstrate the ability to interact with all staff of all levels in a professional manner.
Must have the ability to work with study subjects and the study’s’ research team to complete the research protocol.
Must work well with others as part of a team and demonstrate the ability to coordinate multiple activities.
Requires excellent knowledge regarding human subjects’ research requirements/regulations.
Word processing and data analysis software required

Nice To Haves

Experience as Human Subject Research Specialist II preferred
Professional Research Coordination certification (SoCRA or ACRP) upon hire preferred

Responsibilities

Manages and oversees the activities that establish, monitor and maintain human subject research, including responsibility for ensuring proper staff training.
Plans, directs, monitors and coordinates all phases of human subject research, which may include multi-site, community-based research or multiple therapeutic areas.
Manages, designs, implements and evaluates study changes.
May supervise others.
Serves as study manager at senior professional level for the Principal Investigator, Dr. Robert Block’s Preventive Cardiology Research program.
Provides professional direction and coordination within the project and maintains a working knowledge of the area(s) of expertise by reviewing research literature, abstracts, attending pertinent meetings and seminars.
Oversees human subject research activities for single or multiple sites.
Develops, implements and evaluates study subject requirement strategies, information and data systems and study management systems.
Creates, plans, develops, implements and manages study design, budgets, protocols, consent forms, processes and policies that may include multiple therapeutic areas.
Creates, develops, reviews and approves case report forms and study-specific procedures, manuals and documents.
Communicates and coordinates with Dr. Block to ensure each subject’s safe and proper completion of the study protocol, including weekly meetings with PI.
Ensures the collection of all study data.
Coordinates with Dr. Block to ensure study materials are present and other non-intervention components are obtained, including questionnaires, other study forms.
Trains other staff about activities associated with conducting human subject research specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements.
Manages and mentors research coordinators of various levels.
Develops, delivers and monitors efficacy of training on the conducting of human subject research in accordance with approved protocols and in compliance with the Good Clinical Practices (GCPs), including training on policies and practices used by sponsors for the purpose of meeting regulatory requirements.
Designs, develops, implements, monitors and manages systems and methods to ensure quality, safety, efficiency and consistency in the processing of data.
Reviews study progress, including data, finances, timeframes, documentation and reporting deliverables.
Manages, implements and monitors systems for tracking and evaluating study progression.
Manages the tracking of project expenses and documentation of expenditures and prepares regular reports to Principal Investigator, and division grants administrator.
Ensures payment of study subjects according to the protocol.
Participates in all necessary trainings related to clinical billing and financial management.
Establishes study-specific processes for distribution of study funds.
Manages expenses, equipment and study materials.
Prepares and monitors operating and financial reports and documents for review and analysis.
Develops, documents and implements Standard Operating Procedures (SOPs) at all sites and ensures adherence to established SOPs.
Maintains regular contact with Principal Investigator and other members of the research team, the eRecord electronic health record team, and the RSRB to ensure implementation of project deliverables within timelines, and to assess gaps/needs.
Prepares and submits study protocol revisions to the RSRB.
Serves as the primary communicator for project reporting and compliance, with sponsors and the University of Rochester’s intramural systems.
Maintains competencies as described in human subject protection and good clinical practice guidelines.
Keeps current with all federal, state, sponsor and institutional policies and laws, SOPs and guidelines.
Manages and evaluates resulting study changes.
Demonstrates accountability for continuous learning in accordance with GCPs.
Keeps current with industry standards, best practices and trends in therapeutic areas relevant to research studies.
Other duties as assigned