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.  Revie