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

Opening

Full Time 40 hours Grade 053 Medicine M&D-Immuno;/Rheum Div

Schedule

8:30 AM-5 PM

Responsibilities

Summary:

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 for clinical trials meeting regulatory, University and sponsor requirements for the projects.

Responsibilities:

Administrative Duties

Using expert knowledge of IRB, GCP, FDA, Sponsor and University requirements, develops, plans, and executes protocols and study design(s) by developing, planning and creating source documents and tools that comply with regulations and requirements. To maintain fiscal health of our research mission, ensures site selection and timely start-up of studies by ensuring completion of all regulatory, qualification and feasibility documentation.

Uses critical thinking skills and problem solving skills to execute protocols and ensure compliance with the schedule of events. Plans and coordinates with subjects, investigators, efficacy and safety assessors, lab staff, drug administration and education staff to schedule study visits and procedures within allowable windows. Ensures appropriate resources are available to carry out study visits and procedures by managing study supply inventories, reviewing provider and staff schedules, room utilization schedules, and by working with outside departments for ancillary testing and/or procedures. Using good clinical practices and expert knowledge of the protocol, conducts subject visits and evaluates subjects’ continuing eligibility for study participation by identifying and documenting subjects’ changes in health; notifies PI of safety or efficacy concerns and makes recommendations regarding subjects’ continued participation. Collects, documents, interprets and manages data by performing chart review, conducting interviews, administering questionnaires, maintaining specimen results, reviewing and documenting changes in concomitant medications, and reviewing and documenting changes in adverse events. Ensures data integrity by maintaining complete, accurate, and applicable information.

Gains knowledge and understanding of allergic, immunologic and/or rheumatologic diseases, including disease classification criteria and disease activity indices. Drives subject enrollment by planning, developing and implementing recruitment strategies; directs recruitment coordinator to ensure recruitment targets are met. To evaluate subject eligibility, interprets data in the electronic medical record (EMR) and historical documentation from outside providers. Communicates with potential research subjects in a timely manner and in accordance with good clinical practices. Assesses subject’s ability to comply with the study protocol(s), and willingness to participate freely. Assesses subjects’ understanding and comprehension of the study requirements and their participation in the study.

Accepts fiscal responsibility to ensure complete and accurate reimbursement from Sponsors by reporting invoice-able procedures to finance team(s) and reconciling Post Award Workbooks with finance team. To ensure billing compliance, determines appropriate funding when procuring study supplies, making subject payments, and approving study charges including determining if a charge should be billed to standard of care or research. To support the University’s LEAN initiative, evaluates processes and identifies and implements opportunities to use resources more efficiently.

To ensure compliance with the protocol(s), contract(s), federal and ICH guidelines, prepares, organizes and maintains documentation for study sponsor and regulatory agencies by monitoring expiration dates, study site changes, and protocol amendments. Ensures site-specific requirements are met by reviewing and making changes to centralized sponsor forms and obtaining sponsor approval for such changes. Completes continuing reviews and progress reports by collecting, analyzing and interpreting data.

To validate study endpoints and communicate study data to the PI, lab personnel, and/or sponsor, assesses and interprets which specific data collected on source documents is appropriate to compile and transfer into a database or into sponsor Case Report Forms (CRFs). Ensures HIPAA regulations are followed by planning, developing and implementing security controls for electronic and hard-copy research data.

To ensure Principle Investigator(s) is(are) meeting responsibilities with respect to human subject research, provides training for study staff, tracks safety report review, and communicates with study sponsors, monitors IRB, FDA and other regulatory agencies. Represents the University and the Principle Investigator at appropriate meetings regarding clinical trials.

Deliver Patient Relations:

Enrolls subjects in clinical trials by participating in the informed consent process; enrolls subjects in non-drug clinical studies by obtaining informed consent. Obtains re-consent. Serves as the primary contact for subjects during entire clinical trial or study. Interviews subjects to determine if they have experienced health changes that should be reported as adverse events. Adjusts questioning based on subjects’ responses. Administers questionnaires as appropriate. Reviews concomitant drugs. Assesses compliance with protocol and counsels non-compliant subjects. Obtains vital signs. Obtains and processes biologic samples. Transports and/or ships samples to the research lab, local and/or central clinical lab ensuring that specimens are received and processed in a timely manner.

Qualifications:

Bachelor's degree with major course work in an appropriate health, social or technical field and 3 years of experience in human subject research coordination; or an equivalent combination of education and experience. Prefer previous involvement in research and clinical trials, HSPP Certification, phlebotomy skills, and experience as Human Subject Research Coordinator I.

EOE Minorities/Females/Protected Veterans/Disabled

Job Title: Human Subject Res Coord II

Location: School of Medicine & Dentistry

Job ID: 201964

Regular/Temporary: Regular

Full/Part Time: Full-Time