Sr Human Subject Res Coord
Manages and oversees the activities that establish, monitor and maintain human subject research, including responsibility for ensuring proper staff training. Plans, directs, monitors and coordinates all phases of human subject research, which may include multi-site, community-based research or multiple therapeutic areas. Manages, designs, implements and evaluates study changes. May supervise others.
JOB DUTIES AND RESPONSIBILITIES:
Oversees human subject research activities for single or multiple sites. Develops, implements and evaluates study subject requirement strategies, information and data systems and study management systems. Creates, plans, develops, implements and manages study design, budgets, protocols, consent forms, processes and policies that may include multiple therapeutic areas. Creates, develops, reviews and approves case report forms and study-specific procedures, manuals and documents.
Represents sites, providers, study team, patients, study participants and the University to establish, develop, oversee, monitor and maintain working relationships, positive communications and effective results. Responsible for supporting the contacts and relationships between and among Principal Investigators (PI), research staff, study sites and sponsoring and regulatory agencies.
Manages and mentors research coordinators of various levels. Develops, delivers and monitors efficacy of training on the conducting of human subject research in accordance with approved protocols and in compliance with the Good Clinical Practices (GCPs), including training on policies and practices used by sponsors for the purpose of meeting regulatory requirements.
Designs, develops, implements, monitors and manages systems and methods to ensure quality, safety, efficiency and consistency in the processing of data. Reviews study progress, including data, finances, timeframes, documentation and reporting deliverables. Manages, implements and monitors systems for tracking and evaluating study progression.
Develops, documents and implements Standard Operating Procedures (SOPs) at all sites and ensures adherence to established SOPs.
Establishes study-specific processes for distribution of study funds. Manages expenses, equipment and study materials. Prepares and monitors operating and financial reports and documents for review and analysis.
Keeps current with all federal, state, sponsor and institutional policies and laws, SOPs and guidelines. Manages and evaluates resulting study changes. Demonstrates accountability for continuous learning in accordance with GCPs. Keeps current with industry standards, best practices and trends in therapeutic areas relevant to research studies.
Other duties as assigned.
Bachelor's degree required. 5 years of experience in human subject research coordination required or equivalent combination of education and experience. Experience as Human Subject Research Coordinator II preferred. 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.
EOE Minorities/Females/Protected Veterans/Disabled
Pay Range: $58,800 - $82,300 Annually
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
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Location: School of Medicine & Dentistry
Full/Part Time: Full-Time