RN-Research Nurse - Research-Other
Company: Eisenhower Medical Center
Location: Rancho Mirage
Posted on: June 23, 2022
* Job Objective: A brief overview of the position.
* This position is responsible for coordination and implementation
of Industry-sponsored and Investigator-initiated clinical trials
and research projects. Coordinates and oversees all clinical
operations of research projects. This person participates in
assessing, planning, implementing and evaluating subject care in
clinical research studies and establishes clinical research
organizational policies and procedures as well as carries out
* Reports to
* Director, Research Administration
* Clinical research interns, assistants, and associates to whom
tasks have been delegated
* Ages of Patients
* Blood Borne Pathogens
* Moderate Potential
* Required: BSN or MSN or enrollment in an RN-BSN or RN-MSN program
within 1 year of hire and completion within 5 years of hire (may be
waived for an internal transfer hired before July 1, 2012)
* Required: California RN licensure; American Heart Association
* Required: Certified by the Society of Clinical Research
Associates (socra.org) or Association of Clinical Research
Professionals (ACRPNet.org) within 2 years of hire or upon
* Preferred: Certified by the national nursing organization in the
disease specialty being supported
* Preferred: 2-5 years of clinical trials experience; 2-5 years of
experience in clinical specialty that clinical trials and research
are being conducted in
* Essential Responsibilities
* Demonstrates compliance with Code of Conduct and compliance
policies and takes action to resolve compliance questions or
concerns and report suspected violations.
* Acts as a liaison among the Sponsor, Principal Investigator (PI),
Institutional Review Board (IRB), departments in the health system,
and study participants for study management.
* Provides study information to physicians, nurses, pharmacists,
lab personnel, and other clinicians.
* Arranges in-service trainings as appropriate. Responsible for
implementation, data management, and follow-up of clinical trials
to ensure data accuracy, study participant safety, confidentiality,
protocol compliance, and regulatory compliance as required by the
clinical trial protocol and the study sponsor.
* Assists physicians in identifying eligible patients and in the
informed consent process. Coordinates all aspects of clinical
research activities and management of study participants per
protocol. Oversees study drug administration. Monitors and reports
adverse events according to IRB, institutional, and protocol
* Submits required documentation to IRB including opening/closing
of studies and informed consent documents as well as amendments and
renewals of study protocols.
* Assists Principal Investigator in identifying potential
* Participates in the complete design, planning and conduct of
clinical research projects, including:
* Manages all aspects of site feasibility, site selection, site
initiation, study management, and monitoring visits to ensure that
the protocol as well as all other obligations, responsibilities,
and regulations are followed
* Monitors subject records for quality, data integrity, and
compliance with regulations and organization's standard operating
* Works closely with study sponsor staff members
* Assists with negotiation and monitoring of budgets and contracts
as well as research billing review
* Coordinates patient scheduling of protocol-required
* Manages clinical site activities (regulatory, patient accrual,
data capture and monitoring, and adverse event reporting)
* Develops education/promotional materials to educate patients
about available clinical trials. Develops and maintains a formal
mechanism to ensure that information about the availability of
related clinical trials is provided to patients. Performs community
outreach, including lectures, podcasts, and attendance at patient
support groups to raise awareness about clinical trials
* Maintains an updated list of research studies in various
organizational systems: Epic, IkeNet Clinical Trials Database,
* Utilizes Epic for clinical trial patient management including
associating research patients to the appropriate study as well as
documenting discussions and study visits
* Acts as liaison among the IRB, PI, study sponsor staff, and other
departments. Attends study meetings organized by sponsors (may be
offsite and require travel)
* Develops sufficient product and diagnosis expertise to
communicate directly with clinicians, staff, other departments,
* Assists in tracking and reporting Serious Adverse Events to
sites, sponsor, and IRB in required timeframe
* For investigator-initiated studies, assists in developing
protocols, case report forms, and informed
* Works closely with physicians and staff to facilitate research
and enrollment to trials. Monitors enrollment and reports to PI and
* Maintains knowledge of regulations and establishes compliant
processes for Investigational Device Exceptions (IDEs) and
Investigational New Drugs (INDs) being utilized.
* Coordinates continuing Clinical Quality Management Plan (CQMP),
including quality assurance and quality improvement activities.
* Obtains and handles subjects' biological specimens per
* Maintains inventory log of study drugs/devices.
* Attends study meetings and training programs per study sponsor;
may include travel.
* Provides training to assistants or personnel on protocol
procedures. Maintains training logs.
* Maintains study records per protocol.
* The domains of the clinical research nurse include:
* Scientific Concepts: Knowledge of scientific concepts related to
the design and analysis of clinical trials and protocol
* Adherence to Ethical Standards and Participant Safety Concerns:
Encompasses care of patients, informed consent, aspects of human
subject protection, and safety in the conduct of a clinical
* Investigational Product Development and Regulation: Encompasses
knowledge of how investigational products are developed and
* Clinical Study Operations (Good Clinical Practice): Encompasses
management of clinical trial patients, study management and
compliance with good clinical practice; safety management (adverse
event identification and reporting, post-market surveillance, and
pharmacovigilance), and handling of investigational product.
* Study and Site Management: Encompasses content required at the
site level to run a study (financial and personnel aspects);
patient recruitment and retention; financial stewardship. Includes
site and study operations.
* Data Management and Informatics: Encompasses documentation and
document management, data management, and information technology.
How data are acquired and managed during a clinical trial,
including source data, data entry, queries, quality control and
correction, and the concept of a locked database.
* Leadership and Professionalism: Encompasses the principles and
practice of leadership in clinical research.
* Communication and Teamwork: Encompasses all elements of
communication within the site and between the site and sponsor,
Contract Research Organization (CRO), and regulators; understanding
the teamwork skills necessary for conducting a clinical trial.
* Performs other duties as assigned.
Keywords: Eisenhower Medical Center, Palm Springs , RN-Research Nurse - Research-Other, Healthcare , Rancho Mirage, California
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