This job will involve outpatient and Inpatient studies and will require morning and evening hours.
Coordinates clinical research studies with Study Coordinator-Data, ancillary services and clinical teams
Supervises dose changes or laboratory abnormalities under the direction of the MDs
Orders study specific lab work and protocol specific procedures per study and department protocol/s
Works with research lab services and DMs to maintain lab supplies
Develops in-services for Infusion Clinic Nurses
Works with finance team regarding study/pt. specific study charges
Identifies, Screens, consents and enrolls patients on clinical trials
Performs phlebotomy (PK, PD sampling, EKGs and other) as necessary
Attends investigator and coordinator meetings as applicable
Integrates the workflow of many studies running simultaneously
Serves as a resource and contact person for active protocols
Along with study team, advises sponsor of inconsistencies, errors or any issues of concern that may be identified by a critique of sponsors protocol
Ensures screening, scheduling, correct timing of study visits and coordination of care of research participants is accomplished as written in the research study.
Educates patient/participants and their families to the purpose of clinical research.
Provides education to patients, families and significant others specifically related to research protocol requirements and the cancer diagnosis.
Educates staff about treatment, possible side effects, and complications.
Utilizes critical thinking skills to recognize and solve patient/participant problems.
Utilizes the nursing process and nursing standards to prevent or manage actual/potential patient/research participant problems in the oncology setting.
May provide patient care for patients.
Performs toxicity assessments, grading under the direction of investigator.
Participates in the review of research study data both through internal and quality control/quality assurance and participates in quality improvement processes
Possesses a working knowledge of clinical trial design and conduct.
Demonstrates proficiency in operating multiple electronic applications used for documentation and obtaining results.
Provides information and develops appropriate resource documents, patient diaries and tracking tools for the medical and nursing staff enabling the successful completion of procedures and collection of data as written in the research study plan.
Is able to consistently gather data and follow protocols and/or department guidelines with guidance
Participates in the research treatment plan by reviewing the overall structure, and requirements for each protocol with the principle investigator, or designee.
Organizational management, including, but not limited to, timeliness in completing source documentation, reporting adverse drug experiences, managing workload and managing patient study files.
Liaison between clinical team and research team to develop processes, troubleshoot complications and facilitate communication
Collaborates with medical staff to facilitate and optimize the care of the research patient.
Maintains current PEERS, CITI or NIH Protection of Human Subjects Training Certification annually
Maintains knowledge of current ICH and FDA guidelines. Facilitates and maintains full regulatory compliance and working knowledge of protocol requirements and good clinical practices as set forth by federal regulations
Provides coverage for Coordinators and Research Nurses in other Oncology disease groups
Provides Inpatient Research Coverage when needed
Helps with study feasibility, budgets, via Oncology information and any other required information
Maintains a highly professional and positive attitude
Plans and Coordinates CRT and other team meetings and the information required for those meetings
Other duties as required by Leadership
The Clinical Research Group Research Nurse will have strong interpersonal and organizational skills with excellent attention to detail, ability to multi task and work well under time constraints. The candidate will have excellent computer skills with proficiency in all Microsoft software applications. They will participate in the development of research goals and objectives by attending staff meetings, in-service programs, attending appropriate continuing education opportunities, staff development programs, as well as participating in Quality Improvement initiatives to support implementation of change.