University of Rochester Advancement · 1 day ago
Human Subject Research Specialist II
Saunders Research Building
Full-time
Onsite
Entry, Mid Level
$24.91/hr - $34.87/hr
2+ years expThe University of Rochester is committed to advancing the ideals of Meliora - Ever Better. They are seeking a Human Subject Research Specialist II to manage and coordinate human subject and clinical research activities, ensuring compliance with study protocols and regulations.
Higher Education
Responsibilities
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
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
Qualification
Required
Bachelor's Degree required
2 years of experience in human subject research coordination or equivalent combination of education and experience required
Excellent communication skills required
Solid computer skills with knowledge of word processing, database utilities, internet navigation, and email programs 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
Preferred
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
Company
University of Rochester Advancement
The University of Rochester, one of the nation’s top private research universities, has built a national caliber advancement program in support of the largest campaign in the University’s history.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase