Clinical Research Nurse - 215342
Job Description:
Assist in the development and implementation of ministry and system wide clinical trial processes and procedures to expand clinical trial access to patients across the ministry and system.
Assist in the development and implementation of ministry and system wide policies to guide research activities that advocate for patients, support FDA and other federal human subjects regulations, to assure protocol compliance.
Responsible for coordinating and maintaining diverse activities related to clinical trial nursing across the ministry.
Supports clinical trial activities in private practice physician offices where main responsibility will be subject recruitment for treatment studies from many diverse research agencies at levels to meet accrual commitments.
Coordinates implementation of protocol treatment, care, management and follow up of patients enrolled on highly complex research studies.
This includes patient eligibility verification, coordination of tests and procedures, education of patients, families, Nursing and Medical staff, coordination of investigational vaccines and oral agents, patient advocacy, and assurance of compliance with Federal and International Human Subjects Regulations.
Evaluates operative reports, pathology reports, diagnostic test reports, inpatient and outpatient medical records to determine eligibility, or significance of toxicities to investigational therapy.
Coordinates diagnostic, surgical and other procedures, exams, and specimen collection.
Coordinates specimen collections and adherence to applicable federal regulations.
Works with the physician to provide ongoing research related assessments of patients enrolled to complex early phase treatment clinical trials, develops research plan of care according to patient needs.
Documents all clinical observations to assure and maintain high quality research necessary for meaningful clinical trials, while assuring appropriate patient interventions and education conducted to address identified patient problems.
Provide guidance and support to the research department staff.
Act as a clinical resource for patient issues relevant to research.
Provide clinical research education and in-services to internal and external stakeholders such as inpatient units, cardiac cath lab, special procedures, floor nurses, private practice physician office staff and other medical or nursing staff regarding investigational therapy, potential toxicities, protocol procedures and available resources.
Provide current and accurate protocol resources to investigators and staff.
Attend department cancer conferences and provides information pertinent to current clinical trials as they relate to patient cases presented.
Maintains confidentiality standards for all potential and enrolled patients; complies with federal HIPAA regulations.
Participates in the protocol review and feasibility processes and work with the hospital and physician practice to analyze clinical research protocols to assure clarity of standard vs.
non-standard care requirements (important for billing implications).
Assures ongoing informed consent process and patient advocacy during the process according to federal regulations and guidelines per the Office for Human Research Protections.
Assures ongoing compliance with all Federal regulations and department policies for regulatory documentation of research processes.
Appropriately assures compliance with regulations regarding handling and administration of gene therapy materials or other strictly controlled investigational agents.
Assures compliance with all system and regulatory Quality Assurance requirements.
Institutes controls to assure accuracy, completeness and confidentiality of research data.
Prepares reports and assists with statistical preparation and analysis as necessary for audits or other presentations.
Acts as quality assurance gatekeeper for assurance of enrollment, evaluation and treatment of patients according to protocol, preventing research bias and protecting integrity of all data.
Attention to protocol requirements prevents intentional or unintentional research fraud.
Acts as liaison between sponsoring organization, investigators, physician, patient and all personnel involved in implementation of protocol to facilitate access to studies.
Establishes and maintains procedures/systems for research coordination and data management.
Collects and maintains complete records and statistics on each research study patient.
Attends regional and health system meetings.
Participate in system wide research workgroups.
Attend investigator meetings/various study related training and meetings.
Establishes and promotes positive working relationships within the department, throughout the hospital and between other institutions involved in clinical research.
Attend investigator meetings/various study related training and meetings.
Establishes and promotes positive working relationships within the department, throughout the hospital and between other institutions involved in clinical research.
Generate accrual reports, data analysis and protocol development support.
Requirements:
Active RB license in the state of California.
Clinical Research experience supporting a complex therapeutic area (oncology, rare disease, infectious disease, etc).
Drug trial experience highly preferred.
Schedule:
Mon-Fri, regular business hours 1-2 days WFH a week Recommended Skills Administration Assessments Auditing Billing Clinical Research Clinical Works Estimated Salary: $20 to $28 per hour based on qualifications.
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