Clinical Research Nurse
4 weeks ago
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Under the supervision of the Clinical Research Program Manager, the Clinical Research RN ensures the integrity and quality of clinical trials are conducted and maintained in accordance with federal, state, and local regulations, Institutional Review Board ("IRB") approvals, and Salinas Valley Memorial Healthcare System ("SVMHS") policies and procedures. This position is primarily responsible for the accurate completion of visit procedures and collection of information from study patients according to protocols, and for protecting the health, safety, and welfare of research participants. Supports and serves SVMHS research customers, inclusive of patients who have consented or are considering consent to participate in IRB-approved clinical research protocols, and the principal investigators who wish to conduct research involving human subjects. Follows the Principles of Good Clinical Practice (GCP) in the oversight of clinical research activities at SVMHS.
Demonstrates the ability to coordinate Research and Data activities in a hospital or other setting independently.
Collaborates with Physicians, clinical staff, ROC, external-IRB and clinical trial sponsors.
Is a role model for departmental behavior, and provides and promotes a positive working environment for departmental staff to ensure strong employee morale, motivation and productivity.
Actively participates in study specific site feasibility and trial activation, overall quality assurance, and research regulatory and billing compliance of active clinical trials at the Salinas Valley Medical Clinics.
Serves as the liaison between research affiliates, hospital partners and external vendors/partners (e.g. commercial IRBs and pharmaceutical and medical device manufacturers).
Provides information on state of clinical trials at SVMHS and opportunities for collaboration or participation by component institutions.
Facilitates & monitors compliance with study procedures and GCP standards including but not limited to proper screening of study subjects, Informed Consent forms are explained to study participants and all required signatures are obtained prior to treatment, and subject safety throughout the participation in the trial.
Facilitates site feasibility review (e.g., space, equipment, laboratory services, and pharmacy services) prior to study initiation.
Ensures adherence to applicable rules and guidelines of governing bodies such as FDA, HHS OHRP, TJC, HIPAA, CFR and GCP.
Monitors study activities to ensure compliance with clinical protocols and with all pertinent local, state and federal regulations.
Collaborates with nursing unit Managers and Directors in the care of patients participating in clinical trials, assists to assess nursing staff knowledge of supporting a patient participating in a clinical trial, and provides nursing in-services on an as needed basis as determined by the nursing leadership. Participates in collaborative efforts with physicians and other hospital personnel in developing and maintaining a comprehensive clinical research program.
Performs other duties as assigned.
Conducts interviews with potential research subjects to determine their eligibility for a study based on specific inclusion criteria.
Coordinates the research team's efforts by creating schedules for clinical trials and making sure that tasks are completed on time.
Prepares patients for procedures such as drawing blood or administering
injections, and assisting with examinations and tests during trials.
Collects data on patient health status throughout the study period to ensure that they are safe and able to continue participating in the trial.
Monitors patients' conditions and administering medications as prescribed by a doctor or other healthcare professional.
Records the results of diagnostic tests such as X-rays or blood tests in a patient chart.
Provides nursing care to patients who are participating in clinical trials, including administering medications and providing physical therapy.
Assists researchers with data collection by working with other members of the research team such as statisticians, lab technicians, and physicians.
Education: Bachelor of Science in Nursing (RN) required.
Licensure: Current RN licensure in the State of California required.
Certifications: Maintains specialty certification with professional organization, e.g.; CCRC with the Association of Clinical Research Professionals (ACRP) or CCRP with the Society of Clinical Research Associates (SoCRA) within 90-days of hire. Current Dangerous Goods Shipping & Handling Certificate required at time of offer or prior to start date. Current completion of course on the Protection of Human Research Participants from the Collaborative Institutional Training Initiative (CITI) at time of offer or prior to start date. Current unrestricted California Driver's License - must be able to travel to investigator meetings as needed.
Experience: A minimum of 1 year each of bedside nursing experience with an additional 1 year of experience in the Clinical Research field strongly preferred.
The hourly rate for this position is $54.18 - $67.73. The range displayed on this job posting reflects the target for new hire salaries for this position.
Job Specifications:
? Union: Non-Affiliated
? Work Shift: Day Shift
? FTE: 1.0
? Scheduled Hours: 40
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us
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