Clinical Research Nurse 2

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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Clinical Research Nurse 2 to work at the UHealth Medical campus in Miami, Fl

Core Responsibilities:
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.
1. Educates staff and subjects about protocols, treatment, possible side effects, and complications. May also
collect and handle specimens as required by individual study protocols.
5. Prepares and processes new research proposals and amendments and continually monitors applications and
adverse events.
6. Assists with study completion, data lock, study closeout, and archiving of study files to ensure completeness
and continuity of all study data.
7. Completes ongoing checks of clinical data entered on the case report forms to ensure accuracy and revises
any discrepancies.
8. 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:

• Bachelor’s degree in relevant field

• Valid Florida RN license

• Minimum 3 years of relevant experience

• 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.

Department Specific Functions:

The SCCC 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. Clinical Research Nurse 2 Clinical Research Nurse 2 updated 12.29.22 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.

Primary Duties Include:

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. Clinical Research Nurse 2 Clinical Research Nurse 2 updated 12.29.22 26. 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. 27. Completes mandatory education and training that includes review of age-specific needs and other competencies required by the University. 28. Attends Investigator meetings as required. 29. Maintains a safe working environment through compliance with established policies and procedures and timely reporting of safety variances. 30. Participates in the development of general goals of University Clinical Research Staff. 31. Adhere to all University policies and procedures. 32. Demonstrate the ability to implement a Corrective Action and Prevention Action (CAPA) assessment and follow CAPA related issues through to resolution. 33. Participates in professional activities beyond the departmental level. 34. Mentor and encourage clinical research staff to develop through participation in professional organizations, serving on committees, attending journal presentations, seminars, or conferences.

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 - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

Job Status:

Full time

Employee Type:

Staff

Pay Grade:

H12