Located in Southern California, Eisenhower Health is a not-for-profit hospital seeking a RN-Research Nurse – Research-Oncology.
Education: 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 if hired after July 1, 2012
Licensure/Certification: Required: California RN licensure; American Heart Association BLS Preferred: Certified by the Society of Clinical Research Associates (socra.org) OR Association of Clinical Research Professionals (ACRPNet.org) or by the Oncology Nursing Society (ONS.org). Must become certified upon eligibility.
Experience Preferred: 2-5 years of clinical trials experience; 2-5 years of experience in clinical specialty that clinical trials and research is being conducted in.
The position will be responsible for assisting in the running of Clinical Trials.
- 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 between the Sponsor, Principal Investigator (PI), Institutional Review Board (IRB), departments in 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 assure 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. Coordinate 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 guidelines.
- Submits required documentation to IRB including opening/closing of studies, informed consent documents, and amendments and renewals of study protocols.
- Assists Principal Investigator in identifying potential sponsors/studies.
- Participates in the complete design, planning and conduct process of clinical research projects, including:
Manages all aspects of site feasibility, site selection, site initiation, study management, monitoring visits to assure that the protocol, obligations, responsibilities and regulations are established and followed.
Monitors subject records for quality, data integrity and compliance with regulations and organization’s SOP’s.
Works closely with study sponsor staff members.
Assists with negotiation and monitoring of budgets and contracts and research billing review.
Coordinates patient scheduling of protocol required activities.
Manages clinical site activities (regulatory, patient accrual, data capture and monitoring, adverse events reporting).
Develops education/promotional materials to educate patients on 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, patient groups.
Maintain an updated list of research studies organizational systems: Epic, IkeNet Clinical Trials Database, IRBNet, etc.
Utilize Epic for clinical trial patient management including, associate research patients to appropriate study, documenting discussions and study visits in EPIC.
Acts as liaison between IRB, PI, study sponsor staff and other departments. Attends study meetings organized by sponsors (may be offsite and require travel).
Develops sufficient product/indication expertise to communicate directly with clinicians, staff, other departments, consultants, etc.
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 consent documents. Assists in writing and/or auditing clinical reports.
- Works closely with physicians and staff to facilitate research and enrollment to trials. Monitors enrollment and reports to PI and Director.
- Maintains knowledge of regulations, and establishes compliant processes for IDEs and INDs being utilized.
- Coordinates continuing Clinical Quality Management Plan (CQMP), including quality assurance and quality improvement activities.
- Obtain and handle subject’s biological specimens per protocol.
- Maintain inventory log of study drugs/devices.
- Attend study meetings and training programs per study sponsor; may include travel.
- Provide training to assistants or personnel on protocol procedures. Maintain training logs.
Near Palm Springs and two hours from sunny beaches and mountain resorts, our vibrant community offers an enviable lifestyle including affordable housing, minimal traffic, world-class dining and shopping, and year round recreational activities.
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