University of Rochester Human Subject Res Coord I in Rochester, New York
Full Time 40 hours Grade 051 Cancer Center M&D;
8 AM-4:30 PM
Serve as Coordinator for clinical trials activities involving the University of Rochester Department of Medicine, Division of Hematology/Oncology
Under general guidance and with latitude for exercise of independent judgment, coordinates patient enrollment, schedules and care in Wilmot Cancer Institute (WCI) clinical trials and studies. Monitor conduct of studies assuring compliance with applicable regulatory requirements.
Plan, implement, coordinate, administer and evaluate the care for patients enrolled in several key WCI research studies, including cancer control, behavioral intervention and communication trials for cancer patients and cancer survivors. Provide professional direction with the planning, implementation, coordination, operation and evaluation of key research studies. Maintain a working knowledge of the areas of expertise by reviewing research literature and abstracts, attending pertinent local and national meetings and seminars. Assist with recording and analysis of qualitative data.
- Serves as liaison between study personnel, investigators, hospital staff, patients and their families in all phases of WCI studies. Plan and execute required aspects of the research project working with the Principal Investigator (PI), the Clinical Trials Office, the Research Subjects Review Board (RARB), physicians and other health care professionals which may include, but are not limited to, the following:
- Screen and identify potential study patients by participating in multidisciplinary clinics and reviewing clinic schedules and consult materials
- Maintain patient data, such as, consent forms, letters, and appointment notices. Provide scheduling of study events for patients enrolled.
- Collect clinical data during all phases of care while patient is on-study, complete case report forms.
- Maintain and report patient data for statistical analysis.
- Assist with study audits conducted by independent monitors and federal and governmental agencies or RSRB.
- Assist with data analysis for long term projects.
- Monitor key studies and be familiar with WCI CTO (Clinical Trials Office) standard operating procedures, and verify data ensuring compliance with requirements of the protocol and federal regulations.
- Facilitate 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 State Bureau of vital Statistics) that provide a source of information.
- Coordinates study patient evaluations in the PEAK (Physical Exercise, Activity, and Kinesiology) Laboratory and Cancer Control and Psychoneuroimmunology Laboratory and serves as a liaison between study PIs and Lab directors and staff by performing the following tasks:
- Works closely with PEAK Lab staff to ensure quality programming and safe participant care services.
- Observes research participants and reports any changes in their medical condition to appropriate research staff, PIs, and Lab Director as well as nursing and medical providers as appropriate.
- Recognizes emergency situations and initiates appropriate response by following the direction of the health care providers.
- Coordinate collection of blood samples from phlebotomy, the infusion center, or the Clinical Research Center as appropriate. Processes blood samples according to study protocol. Must be comfortable with basic blood processing procedures including spinning and aliquoting blood samples, and placing them in the appropriate freezers.
- With minimum direction must be able to operate basic laboratory equipment, including pipetman, centrifuges, water baths, biosafety cabinets, etc.
- Manage study biospecimen collection and storage records, and coordinates with laboratory technical staff to have Luminex, ELISA and other assays conducted.
- Serve as point of contact for patients concerning study matters within the University and affiliates. Prepare detailed documentation of treatment and follow-up of enrolled patients. Coordinate oncology and PEAK lab appointments and correspondence with all patients participating in studies. Collaborate with personnel in other departments and facilities to implement patient activities. Consult regularly with Attendings, Fellows and Residents involved with patients enrolled in studies.
- Complete and submit proper study of documentation to be kept on file for study analysis as well as in the CTO, the RSRB or any other applicable site. Write and prepare consent forms, prepare adverse event reports of assigned studies for review and submission to the IRB, the FDA, and any other required agency. Provide ongoing education and information to Fellows and Attendings, regarding developing protocols and current research. Keep informed of protocol availability and addenda/changes.
- Prepare, collate, and submit in a timely manner, patient study information, status reports and updates as necessary for reporting on progress of patients enrolled in studies. Update and maintain database of all study patients enrolled in specific WCI studies to facilitate the preparation of these reports.
Bachelor’s degree in a health related area and one year experience. Excellent verbal and writing skills are required. Knowledge of computer databases, word processing, spreadsheets and graphics packages are important. Active American Heart Association Basic Life Support (BLS) Certification preferred; certification can be completed after date of hiring.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Human Subject Res Coord I
Location: School of Medicine & Dentistry
Job ID: 203929
Full/Part Time: Full-Time