Address
Form of work- 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 research
- Reports to
- Director, Research Administration
- Supervises
- Clinical research interns, assistants, and associates to whom tasks have been delegated
- Ages of Patients
- Adolescent
- Adult
- Geriatric
- Blood Borne Pathogens
- Moderate Potential
- Qualifications
- 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 BLS
- 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 eligibility
- 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
EducationLicensure/CertificationExperience - 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 guidelines.
- 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 sponsors/studies.
- 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 procedures (SOPs)
- 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 activities
- 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, IRBNet, etc.
- 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, 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
- 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 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 protocol.
- 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 compliance.
- 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 trial.
- Investigational Product Development and Regulation: Encompasses knowledge of how investigational products are developed and regulated.
- 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.
Location: Eisenhower Health · Research-Other
Schedule: Full Time, Varies, 8 Hour Shift
