University of Rochester Human Subject Res Coord II in Rochester, New York
Full Time 40 hours Grade 053 Med M&D-Pulmnry;/Crit Care Unit
8 AM-4:30 PM
Coordinate and oversee 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 mainly asthma, fibrosis, COPD and other studies as assigned. Incumbent is independently responsible for recruiting and screening research subjects, scheduling studies, performing sample collection and coordinating all aspects of clinical studies.
- Using independent judgment, oversees and coordinates clinical (including pharmaceutical) research studies in asthma, fibrosis, and COPD, 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, 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.
- Performs primary data collection for clinical studies, including telephone surveys, analysis ofadministrative databases, 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.Assumes responsibility for study drug compliance for patients in clinical trials.Maintains accurate logs of study drug, sample acquisition and ensures samples are distributed to individual researchers in a timely manner.Perform pulmonary function testing on research subjects (including spirometry, diffusing capacity, Lung volumes, Broncho provocation testing, exhaled nitric oxide measurement). Administer bronchodilator for reversibility testing and methacholine/mannitol for bronchial hyper responsiveness assessment.
- 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.
- Responsible for developing study protocols and assuring compliance with study protocols, standard operating procedures, and GCP guidelines.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.
- 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.
- 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.
- Prepares and develops materials for grant applications, manuscripts and oral presentations.
Bachelor’s degree with major course work in an appropriate health, social or technical filed and 3 years of related experience in human subject research coordination; or an equivalent combination of education and experience. Knowledge of word processing and data analysis software. Professional Research Coordinator Certification (i.e., SoCRA or ACRP) preferred.
A degree in Respiratory Therapy or Nursing is strongly preferred. Clinical/patient experience with knowledge of HIPAA regulations and patient safety, enthusiasm/interest in clinical research, and a strong work ethic are essential. Candidate must be a flexible and independent thinker who wishes to work as part of a research team. The candidate must be detailed-oriented with strong organizational skills and ability to multi-task. Candidate must possess excellent written and verbal communication skills. The applicant must hold a valid NY State driver’s license and have reliable transportation. The position will require significant walking between physical locations (including stairs) as well as standing for significant periods of time.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Human Subject Res Coord II
Location: School of Medicine & Dentistry
Job ID: 203706
Full/Part Time: Full-Time