Human Subject Research Spec I

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JOB SUMMARY:

Position Summary:

Work daily on large community-based pediatric asthma interventions within the city of Rochester. Recruit participants into interventions and ensure timely follow-up data collection.  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. Perform data collection procedures, assist with database maintenance, data cleaning, and data analysis. Assist with manuscript and grant preparation. Oversee sample collections and oversee audit preparations.  Assist with hiring, training, and supervising of research staff. 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. Demonstrate efficiency in prioritizing assignments, skill in proactively and independently resolving problems in the field, and recommending and implementing continuous quality improvements. Possess good knowledge of Microsoft Word, Excel, and Outlook.  Experience with Microsoft Access, REDCap, database development or SPSS is desirable.

Requirements:

Bachelor’s degree with major course work in social or technical field; or an equivalent combination of education and experience in human subject’s research coordination. Some evenings and weekends are required. Must have reliable/efficient transportation to travel to schools, homes, healthcare offices and other local sites. Spanish speaking is a plus.

RESPONSIBILITIES:

Conduct participant screening for the research studies:

• Conduct telephone calls and in-person conversations to screen
• potential participants for eligibility and gage interest in a study.
• Conduct detailed screening surveys and use own judgment to
• determine if subject is eligible.
• Schedule home visits with family, and coordinate schedules with other
• staff to conduct home visits.
• Organize and maintain all screening data in a database.

Conduct subject enrollment for the research studies:

• Travel to appropriate sites for subject recruitment, including homes, emergency departments, and schools.
• Explain study in detail and answers all participants’ questions.
• Obtain written informed consent from caregivers and verbal assent from children.
• Conduct interviews and administers surveys to participants.
• Collect breathing measurements (spirometry, eNO), height/weight, and saliva samples from child/adolescent participants.
• Work with children/adolescents to assure comfort with and accuracy of data collection.
• Maintain subject documentation, including memorandums and letters.
• Provide enrollment updates at weekly study meeting, and provide updates daily to director, senior specialists and research nurse.

Ensure timely follow-up data collection for the research studies:

• Conduct telephone, Zoom and in-person (home, school, etc.) interviews to collect follow-up survey data with participants.
• Make sure that all follow-up surveys are conducted within a specific time frame.
• Travel to schools and homes to collect breathing measurements (spirometry, eNO), height/weight, and saliva samples from child/adolescent participants.
• Communicate with primary care, specialty care, and school nurse offices to obtain asthma-related health information.
• Conduct medical record reviews using electronic health records.

Data collection, data entry, and data maintenance:

• Collect data from interviews and other sources from asthma studies.
• Perform on-site validity checks of data and obtains clarification as needed.
• Verify study related information and review subject records to ensure complete and accurate data.
• Enter data into database.
• Run reports from database and prepare documents for IRB, NIH and DSMB reporting.
• Oversee data cleaning procedures (reviewing and correcting other team members data collection forms).
• Oversee audit preparations for IRB/NIH (ensuring information and subject files are up to date and complete).
• Assist with database creation, edits and general maintenance Independently create tables and coding schematic for the databases.

Help to hire, train and supervise research staff:

• Conduct interviews and assist with hiring of student research assistants.
• Assist with organizing and conducting training sessions for the multiple aspects of the asthma interventions including survey administration and data entry.
• Assist in supervising daily student activities including, delegating tasks, reviewing progress, and providing additional training when needed.
• Assist with interviews and training of regular full-time staff.

Assist with compiling and disseminating information learned from research studies:

• Assist with data analysis using SPSS or Excel, conduct bivariate and multivariate analysis.
• Manuscript preparation - draft abstracts and manuscripts.
• Grant support - assist in preparation of grant materials.
• Presentation preparation - independently organize and design presentations (lectures and posters).
• Conduct literature reviews on related topics using resources provided (library, Ovid Medline and other online sources), as needed.
• Communication with study participants, stakeholders, and other study-related personnel.
• Organize subject samples and mail samples to laboratory for analysis; maintain sample results.
• Create and mail study newsletters to families and nurses.
• Organize subject honoraria and mail gift cards to families.
• Communicate with school nurses, school administrators, and medical providers regarding study.
• Attend weekly study meetings and discuss study related issues and provide insightful suggestions for improvement.

Perform other duties as assigned.

QUALIFICATIONS:

• Bachelor’s degree with major course work in social or technical field or Associate’s degree and completion of 6 months in the Human Subject Research Coordinator Trainee Program required
• Or an equivalent combination of education and experience in human subject research coordination required
• Demonstrate excellent interpersonal and communication skills 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.
• Possess good knowledge of Microsoft Word, Excel, and Outlook. 
• Some evenings and weekend shifts
• Must have reliable/efficient transportation to travel to schools, homes, pediatric offices and other local sites.
• Spanish Speaking
• Experience with Microsoft Access, REDCap, database development or SPSS

EOE Minorities / Females / Protected Veterans / Disabled:

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