Sr Human Subject Research Specialist

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.

Job Location (Full Address):

265 Crittenden Blvd, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Part time

Scheduled Weekly Hours:

20

Department:

400110 Public Health Sciences

Work Shift:

UR - Day (United States of America)

Range:

UR URG 110

Compensation Range:

$60,431.00 - $84,603.00

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

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.

Under general guidance, with considerable latitude for independent judgment, serves as study manager at senior professional level for the Principal Investigator, Dr. Robert Block's Preventive Cardiology Research program. Plans, directs, monitors and coordinates all phases of human subject and clinical research. 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. Manages, designs, implements and evaluates study changes.

Excellent communication skills 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. This position includes travel to medical offices and other potential study sites but is otherwise expected to work onsite.

ESSENTIAL FUNCTIONS

• Study Recruitment: 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.

• Study Coordination Management: Communicates and coordinates with Dr. Block to ensure each subject's safe and proper completion of the study protocol, including weekly meetings with PI. These duties include but are not limited to: meeting subjects when they arrive for their appointments; meeting with subjects when they are consented using a paper consent form; and ensuring 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.

• Coordinator Leadership: 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.

• Study Management: 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.

• Protocol Compliance: 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.

• Regulatory Compliance: 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

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree required

• 5 years of experience in human subject research coordination required

• or equivalent combination of education and experience required

• Experience as Human Subject Research Specialist II preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Word processing and data analysis software required

LICENSES AND CERTIFICATIONS

• Professional Research Coordination certification (SoCRA or ACRP) upon hire preferred

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At the University of Rochester, we are committed to fostering, cultivating, and preserving an inclusive and welcoming culture and are united by a strong commitment to be ever better-Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.