Human Subject Res Coord I

Rochester, NY

Responsibilities

General Purpose:

The Human Subject Research Coordinator (HSRC) will provide study coordination of a national study with four years to go funded by the Department of Defense (DOD). This study will be in collaboration with study investigators at URMC, academic medical institutions including Harvard Medical School, University of South Florida and University of California at Irvine, and other study staff. This study includes two sequential clinical trials aimed at assess the use of digital interventions for co-occurring depression and insomnia among U.S. military service Veterans.

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 Project Coordinator and the Principal Investigator. This includes assisting with recruitment activities, fulfilling and tracking participant payments and associated vouchers, assist with team meeting logistics and communication throughout the project period, assist with preparation of monthly, quarterly and annual reports to the study sponsor, assist with IRB continuing review and amendment submissions, assist with developing and maintaining analytic data files, and assist with preparation of dissemination reports and products including literature reviews, editing text and preparing/managing manuscript submissions.

This is a grant-funded role and will run for a 12-month period, with possibility for extension, depending on the needs of the project..

Responsibilities:

Project administration : Coordinates the administrative details required to initiate and conduct 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 closely the Statement of Work, tracking due dates for individual items and reporting on progress at team meetings.

Recruitment : Active in developing human subject recruitment materials with the study recruitment partners and assuring the eConsent process is working properly and developing and maintaining a subject identification file that is kept separate from the study data file.

Data Management : Works with the Project Coordinator to ensure all data are secured within approved parameters and procedures. Assists with download of data and preparation of de-identifed dataset to be sent to the data analysis site at Harvard.

Dissemination: Assists with development of manuscripts and final reports and manages the submission process for these.

Liaison : Acts as liaison with study staff at the other study sites at Harvard, South Florida and UC-Irvine to track study activities, coordinates all study team meetings and maintains agendas and minutes.

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 such as attending SCORE monthly meetings. 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 Principal Investigator and Project Coordinator with these submissions.

Qualifications:

  • Bachelor’s degree required; or equivalent combination of education and experience preferred

  • No previous experience required

  • Or equivalent combination of education and experience e.g. an Associate’s degree and completion of 6 months in the Human Subject Research Coordinator Trainee program required.

  • Word processing and data analysis software

  • Experience conducting sleep research

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

Pay Range

Pay Range: $ 20.92 - $ 29.29 Hourly

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.

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