Sr Human Subject Research Spec
University of Rochester
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):**
601 Elmwood Ave, Rochester, New York, United States of America, 14642
**Opening:**
Worker Subtype:
Regular
Time Type:
Full time
Scheduled Weekly Hours:
40
Department:
400081 General Pediatrics
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:**
GENERAL PURPOSE:
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 up to two employees.
Works closely with Principal Investigators (PIs), Program Director, and research team to manage and oversee several, large community-based pediatric asthma interventions within the city of Rochester.
Exercising independent judgment, creativity, and decision making, the Sr. HSRS will provide research oversight for several ongoing NIH-funded pediatric asthma studies. The Sr. HRSR is a member of a cross-functional team where teamwork, collaboration, challenges and continuous learning are the standard. The Sr. HSRS will gather information, review and interpret data, and report findings. The Sr. HSRS will monitor research data and coordinate staff tasks to ensure timely research processes. The Sr. HSRS will lead staff meetings, assist with formulating goals, and develop protocols and information gathering methods. The Sr. HSRS will prepare IRB, data safety monitoring board (DSMB) and funding (primarily NIH) reports and communications. They will conduct database maintenance, data analysis, dissemination of findings and grant preparation. The Sr. HSRS will be heavily involved in full-time staff hiring, training, delegation of tasks and supervision. The position requires knowledge of organization┐s policies, procedures, and research operations. The position requires excellent attention to detail, awareness of time-sensitive work, and a high level of organizational and communication skills.
The Sr. HSRS will oversee the primary outcome data collection for several studies, including more than 1,000 participant surveys each year. This role includes significant project management, staff training, and data support to ensure timely and accurate data collection. The Sr. HSRS will collect, review and input data, monitor progress towards milestones, and create various databases, dashboards, charts, reports, and analyses to support the research team and their projects.
The Sr. HSRS will independently supervise 10-15 undergraduate student research assistants, including hiring, scheduling, training, delegation of tasks, review and feedback on work, time approval and performance management. Will also supervise undergraduate student interns, and ensure they are meeting their deliverables for course credit. Will hold bi-weekly group meetings, and one-on-one meetings monthly with student employees and interns.
When needed, the Sr. HSRS will support day-to-day operations to recruit and follow-up with research participants. They will explain studies in detail, use own judgment to answer participant questions, provide informed consent, conduct in-person and telephone interviews, collect breathing measurements and saliva samples, complete medical record reviews, and conduct literature searches. Will communicate with and travel to local Rochester schools, emergency departments, pediatric offices, pharmacies, and participants┐ homes in the Rochester area.
Will follow University Research Guidelines for Human Subjects Research during the COVID-19 pandemic. Demonstrates ICARE* values in each of the major responsibilities.
Required Competencies:
Demonstrate excellent interpersonal and communication skills, both verbally and in writing, in interactions with participants, extramural agencies, officials and physicians. Must be flexible, empathetic, and able to engage effectively with diverse populations. Strong project management skills, efficiency in prioritizing assignments and proactively resolving problems; attention to detail and meeting deadlines with competing demands and timelines required. Ability to function both independently, and collaborating with a team, and work in a fast-paced environment and deliver projects in a timely manner required. Possess good knowledge of database development (Access, REDcap), data analysis (SPSS preferred), and Microsoft Office (Word, Excel, Outlook).
RESPONSIBILITIES:
Oversee the primary outcome data collection for NIH-funded research protocols. The follow-up data collection protocols involve tracking and reviewing approximately 1,000 surveys each year.
Track follow-up time points to ensure timely follow-up data collection
Perform daily analysis of volume of follow-ups to direct efforts
Compile monthly and annual follow-up collection reports
Using own judgement, determine next-step for difficult to reach participants
Train research staff on follow-up data collection processes
Supervise research staff in follow-up data collection (delegate surveys, review surveys, provide feedback and ongoing training)
Ensure complete and accurate data by reviewing all surveys, performing validity checks, and obtaining clarification as needed
Organize and clean study data prior to analysis
Provide weekly updates to PISs and program director regarding follow-up survey progress
Compiles annual NIH, DSMB and RSRB/IRB reports
Assist with follow-up data collection from interviews and other sources, as needed
Communicate with primary care offices to obtain information from medical records for participants
Travel to schools to obtain breathing measurements from child/adolescent participants, and collect school health records
Conduct surveys when needed
Hiring, training and supervision of research staff.
Primary supervisor for student research assistant (approximately 10-15 part-time undergraduate students)Reviews resumes, conduct interviews and make hiring decisions for paid student research assistants
Organize and conduct training sessions for the multiple aspects of the asthma interventions including survey administration, data entry, measures collections, safety, etc.
Supervise daily activities including, delegating tasks, reviewing progress, providing feedback and additional training when needed
Conduct bi-monthly student meetings, and meet with students individually at least monthly.
Supports team in full-time staff hiring, training, task delegation and ongoing supervision for approximately 10 HSRSs.
Develop and maintain multiple research databases, run data reports, conduct analysis:
Meet with PIs and Program Director to formulate information gathering methods and develop databases
Independently create REDCap databases for data collection
Independently create tables and coding schematic for the databases
Support maintenance of several study databases
Troubleshoot problems and resolve database issues promptly
Perform validation of all data that is obtained to ensure integrity. Assist in validating data quality and identifying anomalies and errors. Advise and assist research team to correct data inaccuracies as appropriate.
Routinely extract data and run reports from databases, and present finding to PIs and Program Director
Trains staff on how to use databases appropriately
Screen and enroll participants into NIH-funded research studies:
Supports the team in screening of thousands of children each year for possible enrollment into our school-based studies.
Helps to train the team on screening tasks, sets goals, reviews progress, and provides support.
Conduct telephone calls to screen potential participants for eligibility and interest in asthma study
Schedule home visits (or Zoom visits) with family, and coordinate schedules with other staff to conduct visits
Travel to appropriate sites for subject recruitment, including homes, schools and other sites as needed
Explain study in detail, answer participants┐ questions, and obtain informed consent
Conduct interviews with families and administer surveys
Collect breathing measurements (spirometry, FeNO), height/weight, and saliva samples from child/adolescent participants
Work with children/adolescents to assure comfort with and accuracy of data collection
Communicate with participants, as needed
Provide enrollment updates at weekly study meeting, and provide updates daily to study coordinator and asthma coordinator
Compile and disseminate information learned from research studies, and provide professional direction within the projects:
Meet with PIs and program director to formulate project goals and analysis needs
Perform data analyses based on information needsInterpret data/information needs and formulate into specific requests
Using SPSS or Excel, independently conduct bivariate and multivariate analysis
Present results of data analysis to PIs, program director, study team, and stakeholders
Develop and present effective visualizations of data as appropriate, synthesizing information into simplified format for ease of audience understanding (lectures, posters)Draft and present reports for use within the University and presentations at local and national meetings.
Draft abstracts and manuscripts for co-authorship
Attend pertinent meetings, seminars and classes to stay up-to- date in the field
Attend weekly study meetings and discuss study related issues and provide insightful suggestions for improvement
Conduct literature reviews as needed on related topics:
Using resources provided (library, Ovid Medline and other online sources) conduct literature reviews for specific topics to assist in accurately disseminating study information
Perform additional research duties as assigned by PIs and program director
QUALIFICATIONS:
Bachelor┐s degree with major course work in social or technical field and 5+ years of human subjects research experience; or an equivalent combination of education and experience required.
Masters degree and experience with data analysis and dissemination of information preferred.
5+ years experience in human subjects research coordination. Demonstrate excellent interpersonal and communication skills, both verbally and in writing required.
Must be flexible, empathetic, and able to engage effectively with diverse populations required.
Demonstrate efficiency in prioritizing assignments, as well as skill in proactively and independently resolving problems in the field, and recommending/implementing continuous quality improvements required.
Possess good knowledge of Microsoft Word, Excel, and Outlook required.
2-3 year┐s experience with data analysis and dissemination of information preferred
Some evenings and weekends are required.
Must have reliable/efficient transportation to travel to schools, homes, pediatric offices and other local sites required.
Spanish Speaking is a plus preferred.
Experience with Microsoft Access, REDCap, database development or SPSS is desirable preferred.
**EOE Minorities / Females / Protected Veterans / Disabled:**
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.
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**Learn. Discover. Heal. Create.**
Located in western New York, Rochester is our namesake and our home. One of the world’s leading research universities, Rochester has a long tradition of breaking boundaries—always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better.
If you’re looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals
At the University of Rochester, we commit to diversity, equity, and inclusion and united by a strong commitment to be ever better—Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.
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