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The University of Miami/UHealth Department of SCCC CRS has an exciting opportunity for a Full-Time Clinical Research Nurse 2 to work at UHealth in Miami, Florida.

CORE JOB SUMMARY

The Clinical Research Nurse 2 ensures the integrity and quality of clinical research studies are maintained and conducted in accordance with practice guidelines, federal and sponsor regulations, and institutional policies and procedures. Additionally, the Clinical Research Nurse 2 plays a key role in the recruitment of participants and achievement of research objectives.

CORE JOB FUNCTIONS

1. Assesses, troubleshoots, and reports problems with data collection to appropriate managing staff.

2. Identifies desired research outcomes and evaluates and monitors subjects’ responses.

3. Conducts initiation visits and registers patients in clinical studies.

4. Performs study data collection and entry using charts, correspondence, medical records, and relevant

communications. Identifies and procures equipment and supplies needed to fulfill project requirements.

5. Educates staff and subjects about protocols, treatment, possible side effects, and complications. May also

collect and handle specimens as required by individual study protocols.

6. Prepares and processes new research proposals and amendments and continually monitors applications and

adverse events.

7. Assists with study completion, data lock, study closeout, and archiving of study files to ensure completeness

and continuity of all study data.

8. Completes ongoing checks of clinical data entered on the case report forms to ensure accuracy and revises

any discrepancies.

9. Adheres to University and unit-level policies and procedures and safeguards University assets.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities, as necessary.

CORE QUALIFICATIONS

Education: Bachelor of Science in nursing required. Graduated from an accredited nursing program

Certification and Licensing:

Current Florida Registered Nurse license; Current American Heart Association (AHA) Basic Life Support (BLS) for healthcare providers Certification Oncology Nursing Society (ONS) provider card for Chemotherapy and Immunotherapy administration

Certification in a relevant specialty or field (i.e., oncology, diabetes, clinical research, etc.) preferred

Experience: Minimum of 3 years of relevant experience

Knowledge, Skills and Attitudes:

• Strong, effective communication skills with patients, families, and clinical team for innovative patient care and trust
• Ability to collaborate with peers in the best interest of the patient to provide consistent quality of care
• Ability to establish and maintain positive, caring relationships with executives, managers, physicians, non-physician providers, patients/families and other departments and staff
• Ability to adapt and exhibit flexibility to handle new, different, or changing environments
• Demonstrates strong time management skills to prioritize, triage, and act proactivity
• Ability to uphold professional ethics and maintain patient confidentiality

• Knowledgeable on all aspects of patient care including assessing, planning, coordinating, monitoring, and evaluating the patients’ progress through continuum of care
• Knowledge in navigating the electronic medical records and reviewing treatment plans
• Skill in completing assignments accurately and with attention to detail
• Ability to work evenings, nights, and weekends as necessary
• Commitment to the University’s core values
• Ability to work independently and/or in a collaborative environment
• Critical thinking, analytical and problem-solving abilities required as related to various aspects of the protocol
• Good reading, writing, mathematical, organizational and comprehension skills
Demonstrate ability to maintain cooperative working relationships with internal and external units in a clinical research environment

Department Specific Functions

Caring Science
The Clinical Research Nurse provides overall care with loving kindness. As a member of the team, the RN uses creative problem-solving to meet the individual needs and requests of patients. Helps support the hope and faith of patients cared for. Is responsive to patient readiness to learn when they are taught something new. Is respectful of individual patient spiritual beliefs and practices. Creates an environment for the patient that helps them heal physically and spiritually. Establishes a helping-trusting relationship with the patients during their stay with us. Responds to each patient as a whole person, helping to care for their needs and concerns. Encourages patients to speak honestly about their feelings, no matter what their feelings are. The Clinical Research Nurse is accepting and supportive of patient beliefs regarding a higher power if they believe it allows healing.

Leadership Contributes concise, constructive feedback in the provision of care to other staff and leadership, assumes responsibility and delegates to appropriate personnel and follows up to assure completion. Serves as a clinical role model, mentor, and/or preceptor, teaches others and suggests process improvements, provides evidence-based practice suggestions and coaches others to improve, supports changes and recognizes contribution of others.
Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures. Ensures employees are trained on controls within the function and on University policy and procedures.
Establishes Therapeutic and Trusting Relationships Creates and maintains a climate conducive to healing through being present to the patient and family, identifying and managing discomforts; providing emotional support and information; guiding the patient and family through phases of illness and recovery/passage to death and in accordance with the patient's goals and culture. Mobilizes the patient's strengths and abilities towards participation in recovery and control over plan of care.

Diagnostic and
Monitoring Functions Obtains accurate and relevant assessment data and interprets the data as normal vs. abnormal. Determines nursing diagnosis. Modifies patient treatment plans as indicated by patients’ responses and conditions, and physician orders.

Plans and Implements Therapeutic
Interventions Collaborates with the patient, family, and members of health care team to develop an individualized plan of care including discharge planning. Implements nursing and medical interventions safely. Performs appropriate patient tests and safely administers medications within the scope of practice. Administers and maintains accurate records related to medications and treatments as per regulatory bodies, policies, procedures, and physician orders. Evaluates effectiveness of interventions and monitors patient for adverse responses and side effects.
Utilizes available technology platforms which include but are not limited to the use of a telephone, mobile smart device and/or web-based and digital platforms for telehealth encounter. Practices and evaluates telehealth nursing services when applicable in accordance with relevant standards.
Teaching and
Coaching: Patient and Staff Teaching Assesses a patient's and family's learning needs and readiness to learn. Teaches needed information for self-care and illness prevention. Adjusts information and expectations based on responses from patient, developmental levels, physiological and psychological condition, and cultural variations.
Effective Management of Rapidly Changing Situations Ability to rapidly grasp problem situations and respond quickly and appropriately. Identifies the need for and activates emergency protocols.
Adapts to changing work demands and environment.

Monitors and Ensures Quality Healthcare Practices
Monitors own practices and assists in monitoring others for practices related to patient and employee safety and compliance to standards and policies. Looks for opportunities for continual improvement in patient care and the work environment. Adheres to University and unit-level policies and procedures and safeguards University assets.

Organization and
Work Role Function; Priorities Management and Delegation Integrates multiple requests and work expectations by setting priorities, delegating tasks appropriately, and seeking assistance as needed. Contributes to team building through participation in unit programs and meetings.
Contributes to positive morale, using constructive and effective conflict resolution skills. Learns and utilizes the available technology for communication, documentation, and locating information regarding unusual clinical situations, diagnosis, and treatments.
Contributes to the knowledge and skill of other members of the nursing staff through one or more activities such as formal or informal teaching, participation on Shared Governance groups, professional publications and/or presentations.

Education Attains knowledge and competence that reflects current nursing practice. Demonstrates commitment to lifelong learning and is responsible for his/her own professional development and maintenance of knowledge regarding the assigned patient population.

Communication Communicates plan of care in a timely manner to patient and family, as well as the appropriate team members, ensuring compliance with all regulatory guidelines (i.e., HIPAA). Uses best practices for transition of patient care.
Meets diverse communication needs of patients with Limited English Proficiency (LEP).

Professional Practice Evaluation Evaluates own nursing practice in relation to professional practice standards and guidelines, relevant statues, rules, and regulations. Provides focused constructive feedback and guidance with loving kindness to peers in a manner that provides growth and maintains self-esteem. Participates in shared governance, following the ANA Code of Ethics to elevate the professional, integrating the professional practice model and relationship- based care, care delivery model into their practice. Integrates the Magnet Model components into practice.

Critical Thinking Incorporates protocols and standards of care into daily practice. Examines and questions treatment to determine if they are within best practices. Uses sound judgement, decision making criteria, and available resources for drawing conclusions and taking required action. Applies evidence-based practices, approaches and solves problems with a global perspective using creativity and flexibility.

Department Specifics
1. Incorporates the University mission, vision, values, and code of Business Conduct into planning research related patient care and clinical trials activities.
2. Completes all University and department specific required trainings prior to beginning research related activities.
3. 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.
4. Screens patients/patient records to identify potential trial candidates and notify the treating physician and University Clinical Research Staff.
5. 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 Research Nurse scope of knowledge.
6. Educates staff and subjects about protocols, treatment, possible side effects, and complications.
7. Maintains expert knowledge of adverse events and policies regarding reporting.
8. With input as required from the Investigator, assesses and documents adverse events and concomitant medications.
9. Works closely with the protocol University Clinical Research Staff to ensure Serious Adverse Events are documented and reported per protocol and regulatory requirements.
10. Assesses and documents the patient’s compliance and response to protocol treatment.
11. Prepares and reviews necessary data for monitoring visits, audits, and safety summaries
12. Demonstrate the ability to support a clinical audit, including preparation, participation, documentation and follow up.
13. 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.
14. Works closely with the Investigator, Investigational Pharmacist, Comprehensive Treatment Unit (CTU)staff and Clinical Research Services Senior Manager to review the clinical trial treatment order-set and individual patient orders.
15. 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. 16. Enters applicable research related orders and research specific tests and procedures into the chart for the Investigator to sign.
17. Performs research related protocol specific ECGs.
18. Performs simple clinical tasks (research blood draws, vital signs etc.) according to scope of practice, skills, and competencies.
19. 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.
20. Ensures the effectiveness of protocol related education for patient and multidisciplinary team members.
21. 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.
22. Provides a consistent and accessible resource for physicians and clinical staff regarding clinical trials.
23. Works with the Investigator to ensure all clinical trial procedures are performed according to the protocol.
24. Receives clinical trial oral medication from pharmacy and administers the drug, documenting appropriately and providing source documents to the protocol University Clinical Research Staff.
25. Performs second chemotherapy order check prior to administration by another clinical trials nurse.
26. Demonstrates an understanding of and a commitment to customer service values of respect, courtesy, ownership, privacy, professionalism, and responsiveness.

27. 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.
28. Completes mandatory education and training that includes review of age-specific needs and other competencies required by the University.
29. Attends Investigator meetings as required.
30. Maintains a safe working environment through compliance with established policies and procedures and timely reporting of safety variances.
31. Participates in the development of general goals of University Clinical Research Staff.
32. Adhere to all University policies and procedures.
33. Demonstrate the ability to implement a Corrective Action and Prevention Action (CAPA) assessment and follow CAPA related issues through to resolution.
34. Participates in professional activities beyond the departmental level.
35. Mentor and encourage clinical research staff to develop through participation in professional organizations, serving on committees, attending journal presentations, seminars, or conferences.

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The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

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