University of Rochester Human Subject Res Coord I in Rochester, New York
Full Time 40 hours Grade 051 Cancer Center/Clin Trials Ofc
8 AM-4:30 PM
Under general guidance and with latitude for exercise of independent judgment, coordinate patient enrollment, schedules, and care in the Wilmot Cancer Institute Clinical Trials Office (CTO). Monitor conduct of studies assuring compliance with all regulatory requirements.
Serves as a liaison between study personnel, investigators, hospital, staff, patients, subjects and their families in all phases of WCI studies. Assists in planning and executing required aspects of the research project working with the Principal Investigator (PI), staff in the Clinical Trials Office, physicians, and other health care professionals.
Under general direction within policy guidelines and approved protocols:
The candidate will be responsible for coordinating the clinical trial activities related to a recently funded phase II clinical trial investigating hyperbaric oxygen therapy in multiple myeloma patients undergoing autologous transplantation. This study requires coordinating study inpatient and outpatient activities between multiple disciplines including the Bone Marrow Transplant service, the WCI Clinical Trial Office, the UR Wound Clinic that houses the hyperbaric oxygen chamber, and Laboratory Medicine
- Work closely with Cancer Center staff to ensure quality review of potential protocols and safe participant care services.
- Screen and identify potential study subjects by participating in multidisciplinary clinics and reviewing clinic schedules and consult materials.
- Maintain subject data, such as consent forms, letters, and appointment notices.Provide scheduling of study events for enrolled subjects.
- Collect clinical data during all phases of care while subject is on study and complete case report forms.
- Maintain and report subject data for statistical analysis.
- Assist with study audits conducted by independent monitors, federal and governmental agencies, and IRBs/ethics boards.
- Provide continuous data compilation for long term projects across disease groups as needed.
- Monitor key studies and be familiar with WCI CTO standard operating procedures, verify data ensuring compliance with requirements of the protocol and federal regulations.
- Facilitate, with study team, assigned studies and projects.
- Maintain records and correspondence with a variety of agencies and officials (such as outside physicians, medical centers, and nursing homes, the New York Bureau of Vital Statistics) that provide a source of information.
Coordinates study subject evaluations:
- Work closely with department staff to ensure subjects receive study information, are provided with time to ask questions and if interested in participating, sign the IRB approved consent form and are provided with a copy of the signed consent.
- Ensure subjects complete all required interventions (quality of life questionnaires, etc.) per protocol.
- Ensure specimens are collected per protocol and shipped to appropriate laboratory for processing.
- Coordinate collection of study samples from phlebotomy, infusion center or clinic as appropriate.
Point of Contact:
- Serve as a point of contact for subjects concerning study matters within the University and affiliates.Coordinate subject clinic visits by collaborating with personnel in other departments and facilities to ensure proper implementation of study procedures.
- Consult regularly with providers involved with subjects enrolled on studies.
- Complete data entry in a timely manner for all subjects.Prepare adverse event reports as required for review by DSMC, RSRB, FDA, etc.
- Keep providers and staff informed of protocol availability and addenda/changes.
Bachelor’s degree in a health related area, and one to three years of direct patient care or clinical trials related experience. Excellent verbal and writing skills are required. Knowledge of computer databases, word processing, and spreadsheets.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Human Subject Res Coord I
Location: School of Medicine & Dentistry
Job ID: 208197
Full/Part Time: Full-Time