Human Subject Research Spec II
Responsibilities
Captures and coordinates human subject research activities, including multiple site human subject studies in the field of Breastfeeding and Lactation Medicine.
May provide training on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research.
May supervise others.
Works with breastfeeding and lactating families, manages study documents and workflow, collects and processes study samples, and manages regulatory aspects of clinical research studies.
Requirements
Coordinates human subject research activities for single or multiple sites.
Develops, implements and evaluates recruitment strategies, information and data systems and study management systems.
Participates in the planning, development and implementation of study design, budgets, protocols, consent forms, processes and policies that may include multiple therapeutic areas.
Participates in the development, review and approval of case report forms (CRFs) and study-specific procedure manuals and documents.
Represents sites, providers, study team, patients, study participants and the University to develop, monitor and maintain working relationships, positive communications and effective results with regard to the coordination of human subject studies.
Supports the contacts and relationships between and among Principal Investigator (PI), research staff, study sites and sponsoring and regulatory agencies.
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, including data, finances, documentation and reporting deliverables.
Designs, develops, implements, monitors and manages systems and procedures for the purpose of tracking study progression.
Ensures compliance with all applicable regulatory and institutional requirements and standards.
Ensures the integrity and security of all study data at all times.
Implements immediate and appropriate corrective action when inconsistency of activities is identified.
Trains research coordinators and other staff on 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.
Captures and coordinates human subject research activities, including multiple site human subject studies in the field of Breastfeeding and Lactation Medicine.
May provide training on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research.
May supervise others.
Works with breastfeeding and lactating families, manages study documents and workflow, collects and processes study samples, and manages regulatory aspects of clinical research studies.
Qualifications
- Bachelor's degree and 2 years of experience in human subject research coordination required (3 years preferred).
- Or equivalent combination of education and experience.
- Experience as Human Subject Research Coordinator I preferred.
- Experience working with perinatal populations and/or infants preferred.
- If applicable, department specific experience required.
- Experience as a Phlebotomist preferred.
Skills
- Word processing and data analysis software required.
Benefits
The University of Rochester offers a comprehensive benefits package including medical, dental, vision, life insurance, and retirement plans. Additionally, the University provides generous paid time off, flexible spending accounts, and opportunities for professional development and advancement.
Pay
$25.14 - $35.24 per hour.
Schedule
Full time, 40 hours per week.