Clin Research Reg Spt Spec II

Rochester, NY

GENERAL PURPOSE:

Using knowledge of Good Clinical Practice standards, develops, plans, implements, and monitors systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data. This individual will have responsibility for overseeing administrative processes related to human subject research and the recruitment, enrollment, and follow-up of volunteers, meeting regulatory, University and sponsor requirements for the projects.

Under the responsibility of the Principal Investigators (PI) the HSRC II will manage multiple studies, day-to-day operations, carry out study coordination duties according to regulatory/sponsor guidelines, ensuring each study's integrity.

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. Sets up studies in OnCore, RedCap and/or other URMC databases.

  • 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. Perform study recruitment activities. Actively seeking and meeting with patients that meet criteria to enroll them in studies.

  • Keep investigators apprised of study progress, Identify and document adverse events per protocol

  • Prepare for and respond to internal and external audits

  • 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. Maintain all logs, including OnCore entry and research tabs in the according to UR and department SOPs.

  • 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

QUALIFICATIONS:

  • Bachelor’s degree required (health-related field preferred)

  • Mandatory CITI training prior to participating in any research-related procedures.

  • Minimum of 3 years of clinical research or equivalent combination of education and experience required.

  • Experience as Human Subject Research Coordinator I 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

Pay Range: $50,752 - $71,053 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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