University of Rochester Human Subject Res Coord II - 226889 in Rochester, New York
Human Subject Res Coord II Job ID 226889Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening
Full Time 40 hours Grade 053 Emergency Research AdminSchedule
8 AM-5 PM; WKNDResponsibilities
The Human Subject Research Coordinator will work closely with the Research Manager and respective Principal Investigator(s) to coordinate research studies funded by private industry sponsors. Many research projects include evaluating point-of-care diagnostic tools or medical devices for FDA approval. The ideal candidate must be able to work independently with minimal supervision in a fast-paced environment, with multiple projects running simultaneously. Excellent interpersonal skills are required to achieve project goals and objectives. This individual must be comfortable working with various research subject populations, including collegiate athletes, as well as hospital or Emergency Department patients.
(30%) Execute clinical research protocols while directing other staff to complete necessary steps of the research projects. Coordinate subject study activities at the University of Rochester Medical Center and affiliated sites.
(25%) Collect, analyze, and disseminate research data. Report program data and progress to study team. Work with Principle Investigator and senior study staff to develop, implement, and maintain comprehensive databases and files related to programs to include data cleaning and report generation to study sponsors.Ensures the integrity and security of all study data at all times. Initiates, monitors and ensure that all protocol activities are standardized across study sites. Implements immediate and appropriate corrective action when inconsistency of activities is identified.
(15%) Follow Research Subject Review Board regulations and complete application paperwork, meet reporting requirements, and ensure compliance with institution and other regulatory agency requirements.
(10%) Screen and identify eligible subjects for enrollment into research protocols. Complete study procedures with subjects in the Emergency Department, inpatient units, or other locations.
(10%) Perform administrative activities, including coordinating staff and research subjects, managing data, preparing sponsor progress reports, and anticipating project related deadlines. Develop working relationships with external clients sponsoring research activities.
(10%) Identify problems, obstacles, or barriers to successfully completing research protocols; recommend solutions/revisions to the study team leadership.
Competencies and Skills:
Excellent organizational skills and detailed-oriented
Possesses a high degree of self-motivation
Proficiency in managing multiple and competing priorities/demands
Ability to effectively manage moderately complex research protocols/procedures
Exceptional interpersonal, and time management skills; highly collaborative, promotes teamwork
Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services
Bachelor’s degree and 3 years of experience in human subject research coordination; or an equivalent combination of education and experience.
A relevant master’s degree or professional certification and minimum 1 year of relevant experience strongly preferred; or an equivalent combination of education and experience.
Mandatory CITI training prior to participating in any research-related procedures
Clean, valid driver’s license and own reliable transportation is required.
Develops, implements and evaluates recruitment strategies, information and data systems, as well as 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.
Demonstrates written and oral communication skills; excellent organizational skills and attention to detail; efficiency in prioritizing assignments; proactive and independent problem-solver; insightful and trustworthyHow To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled