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
The Research Coordinator will execute research responsibilities as part of the Geriatric Oncology Team. Although tasks and responsibilities will fall under the general guidance of the principal investigator, Dr. Mohile, and Health Project Coordinators, the Clinical Research Coordinator will be required to execute many day-to-day tasks and organization of studies with independent judgment and decision-making. Primary responsibilities include organization and implementation of clinical research studies in geriatric oncology, including coordination of regulatory activities, consenting patients to studies, implementation of study procedures and coordination of study activities with patients and families. The Clinical Research Coordinator will also lead assigned activities for large multisite studies including tracking of complex data, interacting and training research staff at sites, communicating with sites from across the country in terms of answering questions and recruiting physicians. The Clinical Research Coordinator will complete essential study-related tasks including preparing and designing forms and spreadsheets for all upcoming research studies, providing input on study design and Teleforms used in upcoming studies, maintaining database for studies in progress, tracking progress and time points for current studies, data entry in excel or REDCAP software, scanning of Teleforms into database, administering and mailing surveys to clinic or research study patients. The Clinical Research Coordinator will serve as a liaison between study personnel, investigators, primary care physicians, hospital staff, patients and their families in all phases of geriatric oncology clinical research. Involvement in general data organization is needed.
Study Protocol Management:
- Be primarily responsible for the coordination of administrative details related to human subjects’ research such as editing and explaining study information to team members, regulatory personnel, and physicians at University of Rochester and across the country participating in multicenter geriatric oncology studies.
- Ensures all immediate and extended team members understand and adhere to all aspects of all approved protocols, procedures and standards for documentation and communication.These personnel are extensive and include research staff at the University of Rochester as well as research staff throughout the country participating in geriatric oncology studies associated with the National Community Oncology Research Program (NCORP).Under general direction from the Principal Investigator and Health Project Coordinator, trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, process for source documentation and case report form (CRFs) completion, and adverse event reporting.Trainings can occur in person or through web-based virtual training (go-to-meeting).
- Support implementation of research studies and clinical trials with trainees working within the geriatric oncology program.
- Create forms for data management team regarding new protocols.
- Edit, design, and create active protocol checklist and audit forms.
- Review Teleforms for new studies and create “key” for data management team.
- Enter registration information for all new study participants.
- Assist with development of procedures and instruction manuals.
- Support daily operations for research studies and clinical trials as needed.
- Perform other duties and projects as assigned.
Accrual of Patients to Geriatric Oncology Studies
- Plan and execute required aspects of the clinic coordination and research projects working with the Principal Investigator, the Health Project Coordinator, the Clinical Trials Office Manager, physicians and other health care professionals, which may include, but are not limited to the following:
Identifies and provides for scheduling of study events for patients enrolled.
- Assists in human subject recruitment and screening activities, including reviewing study site patient databases and office records for patients that meet the protocol inclusion criteria.
- Participates in developing recruitment strategies. And recruitment tools.
- Conducts telephone interviews to screen potential study candidates or as follow up for study procedures.
- Reviews medical chart historyto verify inclusion criteria are met before enrollment; confirms with Principal Investigator and other physicians as needed
- Consents patients to studies
- Maintains patient data, such as, consent forms, letters, and appointment notices.
- Collects clinical data during all phases of care while patient in on-study, completes case report forms.
- Coordinates appointments and correspondence with all patients enrolled in studies.
- Collaborates with personnel in other departments and facilities to implement patient activities.
- Consults regularly with providers involved with patients enrolled on studies.
- Assists with data entry and preparation of materials for progress reports and publication.
- Prepares and collates patient study information, status reports and updates as necessary for reporting on progress of patients enrolled in studies in order to accomplish a timely completion.
- Reviewing and cleaning databases.
- Reviews and evaluates patient data for adverse events and reports these to the Principal Investigator, Data and Safety Monitoring Committee, and sponsors.
- Assists with study audits conducted by independent monitors and federal and governmental agencies.
- Ensure that all studies remain in compliance with all regulatory requirements concerning approvals, progress reports, amendments, ADR reports, standard operating procedures, and all other aspects of study initiation/closeout.
- Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines.
Participation in Teams and Management
- Attend coordinator meetings’ regarding new protocols.
- Provide backup in the absence of Health Project Coordinator(s).
- Monitor students in Health Project Coordinator’s absence.
- Communicate project indicators to internal management.
- Serves as a liaison between research staff working within different groups (e.g., Clinical Trials Office, National Community Oncology Research Program Research Base and site staff members)
Bachelor’s degree and 1 year of experience in human subject research coordination; or equivalent combination of education and experience. Knowledge of word processing and data analysis software preferred.
Research experience and familiarity with Microsoft office (including word and excel) and some database experience is desired, as well as ability to work independently and as part of a team, and excellent writing and communication skills.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Human Subject Res Coord I
Location: School of Medicine & Dentistry
Job ID: 209105
Full/Part Time: Full-Time