Human Subject Research Spec I

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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:

400057 Medicine M&D-Gastroentrol Div

Work Shift:

UR - Day (United States of America)

Range:

UR URG 106 H

Compensation Range:

$21.78 - $30.53

Responsibilities:

Human 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) and the research nurse coordinator 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

• Reviews study site patient databases and office records for patients that meet the protocol inclusion criteria.
• Screens potential study candidates. Reviews medical chart history with Principal Investigator to verify inclusion criteria are met before enrollment.
• Conducts visits to ensure research participant adherence with protocol requirements (6-minute walk, phlebotomy, EKG)
• Enrolls appropriate patients in non-interventional, observational studies (most notably, PHAR and ACTiPH)

Maintains study continuity

• Reviews and documents the dispensing and returning of study materials, such as study drugs and devices
• Primarily responsible for drug accountability for oral and inhaled drugs in interventional studies.
• Ensures additional training in provided to ensure changes to protocol and documents are communicated and adhered to.

Under supervision, maintains OnCore Database and Study Specific Research Logs

• Maintains logs including OnCore data entry, electronic medical records, according to UR and Department of Medicine Standard Operating procedures
• Assists in entering research data into data collection forms and/or study databases
• 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 relevant others.

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. 

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
• Participates in protocol-related training as required.

Other duties as assigned

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree required or
• Associate's degree and completion of 6 months in the Human Subject Research Coordinator Trainee program required
• Or equivalent combination of education and experience
• Prior experience as a Phlebotomist preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Word processing and data analysis software preferred

LICENSES AND CERTIFICATIONS

• Professional Research Coordinator certification (SoCRA or ACRP) preferred

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