University of Rochester Sr Human Subject Res Coord in Rochester, New York

Opening

Full Time 40 hours Grade 055 Medicine M&D-Immuno;/Rheum Div

Schedule

8 AM-4:30 PM

Responsibilities

*Summary: *

This individual will have responsibility for initiating and managing multiple multi-center company sponsored clinical trials and investigator initiated trials including expenditure controls, budget negotiation and approval, study start-up and planning and compliance with regulations. This person will help supervise and train health project coordinators and other trial staff as well as being a resource for questions and issues requiring a higher level of expertise.

Responsibilities:

Administrative Duties

  • Provides professional direction for the projects.Organizes and plan project start–up including applying for IRB, GCRC and other ancillary approvals. Designs source documents and databases.Prepares documents for study sponsor and regulatory agencies including WIRB, RSRB, GCRC, NIH, and FDA.Prepares reports for FDA and IRB.Evaluates and assists in writing protocols.Writes informed consent forms.Assists in preparation of grants for submission to governmental agencies.
  • Supervises, trains, coaches and mentors study staff. Involved in distributing responsibilities to other coordinators as needed by the division and as the internal environment changes.Acts as a back-up when the Clinical Research Manager is not available.
  • Acts as point person for clinical triage as PI is often not readily available on a daily basis.Uses clinical judgment in reviewing clinical labs and adverse events. Prepares and reviews Serious Adverse Event reports. Reviews and responds to data queries.
  • Prepares, authorizes and maintains a working knowledge of budgets and enrollment.Collaborates with the Clinical Research Manager to control expenditures.
  • Works in conjunction with the Clinical Research Manager to improve operation and financial performance. Assists in implementation of LEAN processes.
  • Develops, enforces, and continually improves the Division’s quality data and regulatory compliance plan. Ensures proper study documentation is on file in the investigators’ files for the Sponsor, IRB, FDA or other federal agencies.
  • Using knowledge of Good Clinical Practice standards, maintains data on patients entered into the study via interviews, questionnaire completion, chart review, specimen results, etc.Assures completeness, accuracy, and applicability of data. Code data for purposes of data entry.
  • Provides training to assure compliance with protocol. Represents our center at appropriate meetings regarding clinical trials for gaining knowledge needed for multi-center trials.
  • Performs Health Project Coordinator duties as needed being a point person for questions and tasks requiring a higher level of expertise.

Deliver Direct Patient Care:

  • Obtain informed consent including drug intervention trials. Evaluate subject understanding of risk. Screens potential volunteers using clinical judgment in reviewing inclusion/exclusion criteria with potential candidate. Obtains detailed medical history.Assist with difficult phlebotomy.Order appropriate medical diagnostic tests.Perform patient visits as needed according to staffing.

Requirements:

Bachelor’s degree and 5 years of experience in human subject research coordination; or an equivalent combination of education and related experience. Phlebotomy skills. HSPP, IATA, CLASP and BLS certification. Prefer previous involvement in research and clinical trials; Registered Nurse.

EOE Minorities/Females/Protected Veterans/Disabled

Job Title: Sr Human Subject Res Coord

Location: School of Medicine & Dentistry

Job ID: 202176

Regular/Temporary: Regular

Full/Part Time: Full-Time