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University of Rochester Human Subject Res Coord II - 232514 in Rochester, New York

Human Subject Res Coord II Job ID 232514

Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 053 Med M&D-Pulmnry/Crit Care Unit

Responsibilities

GENERAL PURPOSE:

Coordinates and oversees human subject research activities and clinical trials involving government, industry-sponsored, and investigator-initiated studies in the Pulmonary and Critical Care Division at multiple sites including the Mary Parkes Center, Strong Memorial Hospital and Highland Hospital in the areas of asthma, COPD and other studies as assigned. Under general direction, the Incumbent is responsible for recruiting and screening research subjects, scheduling studies, performing sample collection and coordinating all aspects of clinical studies as well as assisting in the clinic operations at the Mary Parkes Center and other URMC areas.

RESPONSIBILITIES:

  • Oversees and coordinates clinical (including pharmaceutical) research studies in asthma, COPD, and other studies as assigned at the Mary Parkes Center, Strong and Highland Hospitals. This will include evaluation of clinical data to determine eligibility and co-ordination of study visits and procedures. 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.

  • Assists with primary data collection for asthma clinical research studies, including telephone surveys, analysis of administrative databases, future contact database, analysis of electronic medical records, and analysis of electronic clinical data sources. Coordinates research subject visits and sample collection. Sample collection to include (but not limited to) blood, urine, and respiratory/lung samples (sputum, bronchoalveolar lavage, exhaled breath condensate, urine, and lung tissue). Uses centrifuge to process samples. Perform pulmonary function testing on research subjects (including spirometry, diffusing capacity, Lung volumes, Broncho provocation testing, exhaled nitric oxide measurement

  • 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

  • Reviews, analyzes and manages data and ensures that all documentation is maintained according to industry sponsor requirements, and RSRB/WIRB regulatory guidelines. Keeps current with 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 Good Clinical Practice 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. Prepares for site study visits and represents sites, investigators and study team at research meetings as needed

  • Functions as ‘Asthma Navigator’ for Drs. Georas, Larj and Khurana in the severe asthma clinic at the Mary Parkes Center. Assists with implementing a structured protocol for high risk patients with severe asthma; such protocol to include PRO measures, comorbidity questionnaires, medication adherence and technique review, education and development of personalized asthma action plans, and outreach efforts between clinic visits

    Other duties as assigned.

    QUALIFICATIONS:

  • A degree in Respiratory Therapy or Nursing (LPN or RN) is preferred. Bachelor’s degree with major course work in an appropriate health, social or technical filed

  • 2-3 years of related experience in human subject research coordination required

  • Or equivalent combination of education and experience

  • Knowledge of word processing and data analysis software. Professional Research Coordinator Certification (i.e., SoCRA or ACRP) preferred

    How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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