Human Subject Research Specialist I
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, 14642Opening:
Worker Subtype:
RegularTime Type:
Full timeScheduled Weekly Hours:
40Department:
400037 Medicine M&D-Hospital Med DivWork Shift:
UR - Day (United States of America)Range:
UR URG 106 HCompensation Range:
$21.36 - $29.90The 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 PURPOSEHuman Subject Research Specialist I is an entry level clinical research coordinator responsible for coordinating the activities associated with human subject research. They will work under the supervision and guidance of the Principal Investigator (PI) for the particular study. This role will assume responsibility for less complex clinical research protocols, receiving guidance and instruction from senior level roles.
ESSENTIAL FUNCTIONS
Under supervision, coordinates Human Subject Screening Activities, Recruitment and Subject Visits
- Manages complex scheduling with several time points
- Reviews study site participant databases
- Reviews hospital and office records for patients that meet the protocol inclusion criteria.
- Screens potential study candidates.
- Conducts study subject assessments including telephone calls and interviews
- Engages in successful patient recruitment
Assists Research Coordinators and PI with study document management and tracking
- Ensures accurate, confidential, and complete compilation of data.
- Coordinate and safely complete multiple sequential clinical data collection visits with study participants according to documented procedure, including upload and verification of associated data and data files, ensure post-visit data processing is completed.
- Collect, enter, maintain, and interpret data associated with study recruitment, utilize electronic medical records as needed
Study Maintenance
- Maintains accurate patient research files and records, according to the University of Rochester and department Standard Operating
- Acts as liaison with Sponsor’s Monitor to provide data clarifications, reviews study protocols, ensures thorough understanding and communication
- Responds to questions that arise during the study, communicates and documents adverse events as advised by the PI and ensures regulatory and other documents, such as consent forms and CRFs, are complete, accurate, and available for review.
- Prepares for, participates in, and serves as liaison for scheduled Sponsor monitoring visits (i.e. pre-study inspection, initiation, on-going and close out visits procedures)
- Helps the PI in dissemination of study findings
Complies with Good Clinical Practice (GCP) and Federal Regulations
- Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures, and 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.
- Demonstrates integrity and excellent interpersonal skills
Professional Development
- Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines
- Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies
- Maintains CITI and other trainings/certifications as requires
- Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols and conduct research
- Participates in protocol-related training as required.
Other duties as assigned
MINIMUM EDUCATION & EXPERIENCE
- Bachelor’s Degree required.
- 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).
KNOWLEDGE, SKILLS AND ABILITIES
- Word processing and data analysis software to include qualitative analysis preferred.
LICENSES AND CERTIFICATIONS
- Professional Research Coordinator certification (SoCRA or ACRP) preferred.
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