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 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’s degree in relevant field required

Experience: Minimum 3 years of relevant experience required

Certification and Licensing: Valid State of Florida RN license and BLS required

Knowledge, Skills and Abilities:

• Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
• Teamwork: Ability to work collaboratively with others and contribute to a team environment.
• Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
• Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.

Department Specifics

The Clinical Research Nurse 2 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 Research Nurse 2 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 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 Research Nurse 2 performs all steps of the nursing process 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 Research Nurse 2 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.

Department Specific Functions

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 09.22.23

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

Department Qualifications

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 relevant specialty or field (i.e., oncology, clinical research, etc.) preferred

Experience: Minimum of 3 years of relevant experience

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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 - 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.

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