Human Sub Research Spec II

University of Rochester•City of Rochester, NY

20h•Onsite

About The Position

The Human Subject Research Specialist II is a mid-level clinical research coordinator responsible for assisting in the planning, coordinating, implementing, monitoring, and evaluating human subject research activities within the division of Infectious Diseases. This role involves working closely with study team members and other staff/faculty/study sites to ensure study coordination while maintaining study participant safety and adherence to approved protocols, regulatory guidelines, and operational procedures.

Requirements

Bachelor’s degree required
2 years of experience in human subject research coordination required or equivalent combination of education and experience required
Word processing and data analysis software required

Nice To Haves

Experience as a Phlebotomist preferred
If applicable, department-specific experience required
Professional Research Coordinator certification (SoCRA or ACRP) upon hire preferred

Responsibilities

Administers all protocol-required study procedures on subjects
Facilitate daily coordination of clinical trial activities for the infectious disease research clinic, including but not limited to diseases of respiratory pathogens such as COVID-19, influenza, and RSV.
Initiates, monitors, and ensures that all protocol activities are standardized across study sites.
Includes performing procedures, including but not limited to nasal swabs, nasal washes, venipuncture, and urine collection.
Reviews and interprets study guidelines for next steps necessary for the processing and/or shipment of samples
Implements immediate and appropriate corrective action when an inconsistency in activities is identified.
Ensures compliance in the reporting of subject serious adverse events (SAE) and filing of these in a timely manner to sponsors and IRBs.
Independently manages and coordinates enrollment of participants, including performing chart review/pre-screening for eligibility, developing/implementing/evaluating recruitment strategies, collecting data to initiate study visits, enrolling and consenting study subjects, confirming eligibility, and coordinating subject visits.
Manages and organizes case report forms, source documents, and research records.
Accurately enters research data into data collection form and/or study databases.
Conducts quality checks for data accuracy as needed.
Designs, develops, implements, monitors and manages systems and procedures for the purpose of tracking study progression.
Assists with the design of study data entry forms as needed.
Collect and maintain subject data in designated subject databases and manage regulatory binders for assigned studies.
Participate in entering the study data into appropriate EDCs (Electronic Data Capture) systems, ensuring all data meets study-specific requirements as needed.
Develops, implements, and monitors systems and methods to ensure quality, safety, efficiency, and consistency in the processing of human subject research data.
Ensures compliance with all applicable regulatory and institutional requirements and standards.
Maintains regulatory records and necessary correspondence.
Works under the direction of the Manager of Quality Assurance to assist with audits and responding to audit findings, as well as assisting with study sponsor monitoring visits and correspondence.
Ensures the integrity and security of study data at all times.
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.
Demonstrates accountability for continuous learning following GCP 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.
Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
Maintains CITI and other training/certifications as required.
Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols.
Trains junior staff on activities associated with conducting human subject research in compliance with Good Clinical Practice guidelines.
May direct the activities of subordinate staff.
Assists Finance Administrators with budget development, coordinates and monitors financial data for budget and variance reporting.
Other duties as assigned