Human Subject Res Coord I
Rochester, NY
Responsibilities
Position Summary:
The Human Subject Research Coordinator (HSRC) will provide study coordination and collaboration with study investigators for QI, pilot projects, and research occurring in the UR Health Lab as well as in collaboration with partners at URMC (e.g., Pediatrics) external institutions, and companies /start-ups.
This position is a full-time position, with specific responsibilities (described below). The HSRC will be responsible for implementation and oversight of the study protocols under the supervision of the UR Health Lab project leads. This includes assisting with recruitment activities, fulfilling and tracking participant engagement, assist with team meeting logistics and communication throughout the project period, assist with preparation of monthly, quarterly and annual reports to the study sponsor, IRB continuing review and amendment submissions, developing and maintaining analytic data files, and assist with preparation and dissemination reports and products including literature reviews, editing and preparing/managing manuscript submissions. Additional projects may involve qualitative data collection (e.g., interviews). The HSRC will also be involved with engaging students/trainees across the UR/URMC enterprise in projects, and contribute to team brainstorming, project & study design and implementation activities.
Responsibilities:
Project administration : Coordinates the administrative details required to initiate and conduct Q/I projects, pilot studies and human subject research, including receiving, distributing and explaining study information, such as protocol and human subject recruitment materials, to immediate team members and at partner sites. Maintains a project timeline that tracks progress at team meetings. Collaborates with Health Lab members on emerging projects germane to the Health Lab.
Recruitment : Active in developing human subject recruitment materials with the study recruitment partners including an eConsent process; developing and maintaining a subject identification file that is kept separate from the study data file. May establish randomization procedures and documents. Develops and manages REDCap data collection with initial support. Reports any difficulties with recruitment or site issues; develop strategies to problem solve & implements solutions as needed with direction from project leads.
Data Collection & Management : Runs subjects through protocols with ethical and legal data collection. Works with the project leads to ensure all data are secured within approved parameters and procedures. Assists with download of data and preparation of de-identified dataset as needed. Keeps devices secure and up to date.
Dissemination: Assists with development of manuscripts and final reports and manages the submission process for these. May contribute or take the lead on papers and presentations.
Liaison : Acts as liaison with project/ study staff across sites; communicates clearly and effectively with partners and project leads. Coordinates all study team meetings and maintains agendas and minutes.
Attends Health Team Lab meetings and other meetings as scheduled.
Regulatory/Reporting : Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines and makes recommendations. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines and may do so by attending coordinator meetings through the CTSI. Makes recommendations and implements changes as appropriate.
Takes the primary role in prepping all reports due to the Study Sponsor and to the Research Subjects Review Board. Maintains a calendar of all due dates. Assists the research team for each project in staying up to date on reports and requirements. Prepares for audits as needed.
Qualifications:
Bachelor’s degree (graduation by June 2023) required
Completion Human Subject Research Coordinator Trainee program or equivalent preferred
One-year experience conducting Q/I and/or research with some independence.
Windows, Microsoft Word, Microsoft Excel required
Strong organizational, communication, and interpersonal skills required
Some knowledge of data analysis & management software preferred
Comfort with running subjects using a protocol required
Human Subjects Protection Program (HSPP) required
NIH' s Good Clinical Practice training prior certification preferred
The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled
Location: Medical Faculty Group
Full/Part Time: Full-Time
Opening: Full Time 40 hours Grade 051 Health Lab
Schedule: 8 AM-5 PM