Human Subject Research Specialist II

University of Rochester • City of Rochester, NY

8d • $25 - $35

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. 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 studys’ 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 potentially other study sites.

Requirements

• Bachelor’s Degree required
• 2 years of experience in human subject research coordination or equivalent combination of education and experience required
• Excellent organizational and office management skills required; meticulous attention to detail is essential.
• Demonstrated ability to maintain confidentiality
• Excellent communication and interpersonal skills are necessary
• Possess advanced computer skills to use a variety of electronic or online systems for communication and administrative purposes.
• Ability to manage multiple activities under pressure and demonstrated ability to meet deadlines in a timely manner.
• Ability to interact with all levels of faculty and staff from other departments throughout the University as well as outside agencies.
• Must be able to demonstrate initiative and resourcefulness in managing priorities and take responsibility for accomplishing his/her own work while maintaining confidentiality of information.
• High degree of professionalism, excellent time management, and problem solving abilities.
• Leadership, accountability, discretion, integrity, strong organization skills, initiative, team player.
• Ability to work independently in an interdisciplinary team environment.
• Exceptional customer service skills.
• Strong analytical skills and experience with data analysis programs and software.
• Candidate must have a valid driver’s license to travel to multiple sites and locations throughout the region.

Nice To Haves

• Prior clinical and/or clinical research experience, and demonstrated informatics and/or EHR experience, preferably in the context of primary care and cardiovascular health preferred.
• Experience with eRecord preferred.
• Prior certification in human subject protection program and completion of good clinical practices training.

Responsibilities

• Subject Recruitment: Oversees and coordinates human subject research activities for multiple sites. Develops, implements and evaluates recruitment strategies, information and data systems, as well as study management systems. Participates in the planning, development and implementation of study design, budgets, protocols, consent forms, processes and policies that may include multiple therapeutic areas. Participates in the development, review and approval of case report forms (CRFs) and study-specific procedure 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.
• Protocol Compliance: 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
• Data Management: Coordinates, develops and maintains project databases using REDCap. Analyzes project data and prepares draft reports; makes recommendations for publications, grant requests or the like. Manages all study data in a safe and secure RSRB-approved location within her/his office and on the Department of Public Health Science’s computer server.
• Fiscal Management: 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.
• Other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees