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Clinical Research Nurse 1
Company: University of Miami
Location: Coral Gables, FL
Employment Type: Full Time
Date Posted: 08/19/2022
Expire Date: 10/19/2022
Job Categories: Healthcare, Other
Job Description
Clinical Research Nurse 1
The Clinical Trials Nurse, Level 1 delivers patient-family centered care in a culturally competent manner utilizing evidence-based standards of quality, safety, and service while ensuring population-specific patient care and compliance with the research protocol in an ambulatory setting. The Clinical Trials Nurse, Level 1 plays a key role in the recruitment of participants and achievement of research objectives. Additionally, ensures that the integrity and quality of clinical research studies is maintained with some guidance and that studies are conducted in accordance with practice guidelines, federal and sponsor regulations, and institutional policies and procedures. Provides care to patients, practicing in accordance with the Scope and Standards of Nursing Practice of the Florida Nursing Practice Act, regulatory requirements, standards of care, and institutional policies and procedures. Within that role, the Clinical Trials Nurse, Level 1 performs all steps of the nursing p rocess including assessing/screening of patients; interpreting data; planning, implementing, and evaluating care; coordinating care with other providers; and teaching the patient and family the knowledge and skills needed to manage their care and prevent complications while ensuring compliance with the research protocol. As a professional, monitors the quality of nursing care provided and nurtures a compassionate environment. The Clinical Trials Nurse, Level 1 delivers care that supports the UHealth mission to be a state-of-the-art academic medical center by participating in transforming patient care through innovative research.

The CRN will incorporates the University mission, vision, values, and code of Business Conduct into planning research related patient care and clinical trials activities. Conveys a basic knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in the conduct of research and car e of participants. Completes all University and department specific required trainings prior to beginning research related activities. Provides clinical trial support in the hospital and/or clinic setting to ensure University patients are offered appropriate clinical trials following Good Clinical Practice standards. Screens patients/patient records to identify potential trial candidates and notify the treating physician and University Clinical Research Staff. Assists the Investigator obtain subject informed consent following the University Clinical Research Staff Informed Consent Process 301-05. This involves spending time with the patient and family to provide detailed information about the clinical trial and answer any questions arising within the Clinical Trials Nurse scope of knowledge. Educates staff and subjects about protocols, treatment, possible side effects, and complications. With input as required from the Investigator, assesses and documents adverse events and concomit ant medications. Works closely with the protocol University Clinical Research Staff to ensure Serious Adverse Events are documented and reported per protocol and regulatory requirements. Assesses and documents the patient’s compliance and response to protocol treatment Collaborates closely with protocol University Clinical Research Staff. Provides University Clinical Research Staff with the Informed Consent Document Form and all source documentation required to determine eligibility and maintain compliance. Works closely with the Investigator, Investigational Pharmacist, Comprehensive Treatment Unit (CTU) staff and Clinical Research Services (CRS) Senior Manager to review the clinical trial treatment order-set and individual patient orders within 6 months of hiring. Provides potential and registered clinical trial patients with contact information to ensure that patients and families have an avenue to direct questions about the clinical trial that they were offered. Enters ap plicable research related orders and research specific tests and procedures into the chart for the Investigator to sign. Performs research related protocol specific ECGs. Performs simple clinical tasks (research blood draws, vital signs etc.) according to scope of practice, skills, and competencies. Provides conduit between physicians, allied health professionals, nursing staff and clinical trial patients regarding trial related issues to maintain a safe environment for the patient while maintaining compliance. Communicates with the Investigator, patients, families, clinical staff and University Clinical Research Staff to ensure that treatment plans and research related interventions and activities are understood and scheduled appropriately. Provides a consistent and accessible resource for physicians and clinical staff regarding clinical trials. Works with the Investigator to ensure all clinical trial procedures are performed according to the protocol. Receives clinical trial oral medication from pharmacy and administers the drug, documenting appropriately and providing source documents to the protocol University Clinical Research Staff once Oncology Nursing Society (ONS) provider certification card is obtained and competencies are checked. Performs second chemotherapy order check prior to administration by another clinical trials nurse once ONS provider certification card is obtained and competencies are achieved. Demonstrates an understanding of and a commitment to customer service values of respect, courtesy, ownership, privacy, professionalism, and responsiveness. Initiates and maintains open communication with other members of the team to assure that the patient and family receive the full scope of interdisciplinary expertise and services along with care provided by participation in a clinical trial. Completes mandatory education and training that includes review of age-specific needs and other competencies required by the University. Attends Investigato r meetings as required. Maintains a safe working environment through compliance with established policies and procedures and timely reporting of safety variances. Participates in the development of general goals of University Clinical Research Staff. Adhere to all University policies and procedures. Discuss the principles of Corrective Action and Prevention Action (CAPA) Plans, when they are needed and the process for completing, managing, and following up on CAPA plans. Participates in professional activities beyond the departmental level Begins to mentor and train new nurses.

QUALIFICATIONS: Education: Bachelor’s degree in relevant field Certification and

Licensing: Valid Florida RN license

Experience: No prior experience required
Knowledge, Skills, and Attitudes:
Skill in completing assignments accurately and with attention to detail.
Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
Ability to process and handle confidential information with discretion.
Ability to work evenings, nights, and weekends as necessary.
Ability to communicate effectively in both oral and written form.
Ability to work independently and/or in a collaborative environment
Contact Information
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