URMC Department of Psychiatry
Human Subject Research Specialist II
URMC Department of Psychiatry, Rochester, New York, United States
Human Subject Research Specialist II
URMC Department of Psychiatry
Job Location (Full Address):
601 Elmwood Ave, Rochester, New York, United States of America, 14642
Worker Subtype:
Regular
Time Type:
Full
Scheduled Weekly Hours:
40
Department:
400626 Psychiatry M&D
Work Shift:
UR - Day (United States of America)
Compensation Range:
$24.91 - $34.87
Compensation Range Note: 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:
This position provides coordination for a research study in the URMC Psychiatry Department and entails coordinating, directly conducting, and supervising all stages of human subject's research from recruitment to follow-up, interacting with research participants, and supervising student RAs. Coordinates human subject research activities which may include multiple-site human subject studies. Will provide training on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research. The HSRC II will be in charge of the student RAs and will train them. Will be required to work 40 hours a week, one evening a week, one Saturday a month will be required.
Essential Functions
Participant recruitment and enrollment: Oversees, coordinates and conducts human subject research activities for single or multiple sites. Recruits and enrolls participants. Is required to work one evening a week and one Saturday per month.
Recruitment strategies and materials: Develops, implements and evaluates recruitment strategies, materials, information and data systems, as well as study management systems.
Participant retention: Follows up with study participants regarding assessments and document communications, including protocol deviations.
Supervisory duties: Trains research staff (e.g., student RAs; new fulltime 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. Directs the activities of subordinate staff and relevant others to gather, compile and analyze study information.
Data Management: Develops, implements and monitors systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data. Reviews study progress, conducts data quality checks monthly, ensures data files are updated in a proper timeframe, codes data, cleans data, creates databases for manuscript preparation.
Regulatory: Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures, guidelines, and implements and monitors resulting study changes. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies and designs, implements and monitors resulting study changes.
Minimum Education & Experience
2 years of experience in human subject research coordination – Required
or equivalent combination of education and experience – Required
Experience as Human Subject Research Coordinator – Preferred
Knowledge, Skills and Abilities
Word processing, Excel, and data analysis software (e.g., SPSS) – Required
Licenses and Certifications
Professional Research Coordinator Certification (SoCRA or ACRP) – Preferred
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture 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 characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
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Job Location (Full Address):
601 Elmwood Ave, Rochester, New York, United States of America, 14642
Worker Subtype:
Regular
Time Type:
Full
Scheduled Weekly Hours:
40
Department:
400626 Psychiatry M&D
Work Shift:
UR - Day (United States of America)
Compensation Range:
$24.91 - $34.87
Compensation Range Note: 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:
This position provides coordination for a research study in the URMC Psychiatry Department and entails coordinating, directly conducting, and supervising all stages of human subject's research from recruitment to follow-up, interacting with research participants, and supervising student RAs. Coordinates human subject research activities which may include multiple-site human subject studies. Will provide training on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research. The HSRC II will be in charge of the student RAs and will train them. Will be required to work 40 hours a week, one evening a week, one Saturday a month will be required.
Essential Functions
Participant recruitment and enrollment: Oversees, coordinates and conducts human subject research activities for single or multiple sites. Recruits and enrolls participants. Is required to work one evening a week and one Saturday per month.
Recruitment strategies and materials: Develops, implements and evaluates recruitment strategies, materials, information and data systems, as well as study management systems.
Participant retention: Follows up with study participants regarding assessments and document communications, including protocol deviations.
Supervisory duties: Trains research staff (e.g., student RAs; new fulltime 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. Directs the activities of subordinate staff and relevant others to gather, compile and analyze study information.
Data Management: Develops, implements and monitors systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data. Reviews study progress, conducts data quality checks monthly, ensures data files are updated in a proper timeframe, codes data, cleans data, creates databases for manuscript preparation.
Regulatory: Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures, guidelines, and implements and monitors resulting study changes. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies and designs, implements and monitors resulting study changes.
Minimum Education & Experience
2 years of experience in human subject research coordination – Required
or equivalent combination of education and experience – Required
Experience as Human Subject Research Coordinator – Preferred
Knowledge, Skills and Abilities
Word processing, Excel, and data analysis software (e.g., SPSS) – Required
Licenses and Certifications
Professional Research Coordinator Certification (SoCRA or ACRP) – Preferred
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture 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 characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
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