Coordinates human subject research activities which may include multiple site human subject studies. May provide training on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research. May supervise others.
Oversees and manages the regulatory details for multiple research studies and clinical trials. Plans, develops, modifies, approves, and maintains regulatory and study documentation. Manages and submits study applications, amendments, and continuing reviews for IRB approval. Ensures all regulatory requirements are met and documented. 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 studies. Implements immediate and appropriate corrective action when inconsistency of activities is identified.
Serves as the liaison between research teams, IRB specialists, and study sponsors to facilitate communication, resolve issues, and enhance collaboration. Schedules meetings, attends, and prepares minutes. Coordinates all aspects of research team's attendance and participation at conferences and meetings. 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. Responsible for supporting the contacts and relationships between and among Principal Investigator, research staff, study sites, sponsoring and regulatory agencies.
Develops, implements and evaluates recruitment strategies and enrolls research subjects using a variety of registries, conference and clinic visit data, social media, and phone and mail vehicles. Manages and updates registries used for subject recruitment. Facilitates visits in accordance with IRB protocols. Performs study related procedures as outlined in study protocols. Resolves questions and concerns received from study subjects. 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. (25%) Develops and manages research databases for studies and registries. Develops queries and exports research data used for analysis and preparation of presentations, abstracts, and publications. Mentors and trains other study coordinators and staff about activities with conducting human subject research specific to study protocols, guidelines, and sponsor requirements. Directs the activities of others to gather, compile and analyze study information.
Ensures patient clinical care resources. Coordinates and schedules appointments, and works with multidisciplinary teams for the provision of additional needed resources. Coordinates and monitors financial data for budget and variance reporting, and for compliance with all institutional requirements for adequate system controls. Keeps current with study specific training, institutional certifications/policies, industry standards and best practices, all federal, state, sponsor and institutional policies and laws, standard operating procedures, guidelines, and implements and monitors resulting study changes. Demonstrates accountability for continuous learning in accordance with guidelines.
Bachelor's degree and three years of experience in human subject research coordination; or an equivalent combination of education and experience.
Knowledge of word processing and data analysis software preferred.
Professional Research Coordinator Certification (e.g. SoCRA or ACRP) and experience as Human Subject Research Coordinator I preferred.
Must have strong attention to detail, interpersonal skills and communication skills both verbal and written.
Internal Number: 218158
About University of Rochester
The University of Rochester Medical Center (URMC) is one of the nation’s leading academic medical centers. It forms the centerpiece of the University of Rochester’s health research, teaching and patient care missions.
The University of Rochester Medical Center is a private, coeducational, nonsectarian, and nonprofit research university.
The medical center includes Strong Memorial Hospital, the Eastman Institute for Oral Health, the University of Rochester School of Medicine and Dentistry, with its faculty practice (University of Rochester Medical Faculty Group), and the University of Rochester School of Nursing