Human Subject Research Coord II
The part-time research coordinator (20hrs/wk flexible schedule to be determined) will collaborate to conduct pediatric research studies with a focus on children with severe disabilities (children with medical complexity) and their families. Our research team’s goal is to: 1) Identify family wellness processes associated with caregiver adaptation, and 2) develop and test parent peer support programs that enhance caregiver adaptation to improve child health outcomes and healthcare utilization.
As part of our program, the research coordinator will closely partner with the Principal Investigator (PI), Dr. Nate Bayer, in the planning, coordinating, implementing, monitoring, and evaluating of our studies. Day-to-day responsibilities will include consenting/enrolling participants, study-related administrative tasks monitoring and adhering to regulatory and financial standards, performing caregiver interviews, conducting qualitative data analysis (mentored by the PI), literature review, and writing or contributing to academic products (abstracts, posters, manuscripts, perspective pieces). Additional responsibilities will include writing research protocols, submitting them to the IRB, drafting study instruments, and leading and training other junior study personnel. Study methods will include telephone and in-person communication with patients and their caregivers, medical chart abstraction, and other duties as assigned.
JOB DUTIES AND RESPONSIBILITIES:
Oversees and 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. Initiates, monitors and ensures that all protocol activities are standardized across study sites. 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.
Coordinates and monitors financial data for budget and variance reporting and for compliance with all institutional requirements for adequate system controls.
Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures and guidelines. Demonstrates accountability for continuous learning in accordance with 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.
Other duties as assigned.
Bachelor’s degree (with course work in health, social, or psychology related field preferred) and 3 years of experience in human subject research coordination; or an equivalent combination of education and experience required.
Experience as Human Subject Research Coordinator I preferred
Certified Clinical Research Coordinator and/or nursing degree desirable/preferred. Phlebotomy certification desirable.
Word processing and data analysis software required
Professional Research Coordinator certification (SoCRA or ACRP) preferred
The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion 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 status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.
How To Apply
All applicants must apply online.
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