Clinical Research Nurse 2

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The Clinical Translational Research Site has an exciting opportunity for a full-time Clinical Research Nurse 2 to work on-site 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

• Assesses, troubleshoots, and reports problems with data collection to appropriate managing staff.
• Identifies desired research outcomes and evaluates and monitors subjects’ responses.
• Conducts initiation visits and registers patients in clinical studies.
• 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.
• Educates staff and subjects about protocols, treatment, possible side effects, and complications. May also collect and handle specimens as required by individual study protocols.
• Prepares and processes new research proposals and amendments and continually monitors applications and adverse events.
• Assists with study completion, data lock, study closeout, and archiving of study files to ensure completeness and continuity of all study data.
• Completes ongoing checks of clinical data entered on the case report forms to ensure accuracy and revises any discrepancies.
• 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 required
• Minimum 3 years of relevant experience required
• Valid State of Florida RN license 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 ADDENDUM

Department Specific Functions

1.Work with CTRS lead nurse to ensure that nursing services, policies, and procedures are in alignment with the regulatory and compliance guidelines at institutional and federal levels.

• Participate in the oversight of participant visit scheduling to ensure adequate coverage.
• Assist the lead nurse in weekly meetings of clinical research staff to ensure that challenges and issues are addressed promptly and efficiently.
• Assist with review and updates of SOPS relating to the CTRS as needed.
• Participate in the onboarding of all new CTRS clinical research nurses and medical assistants
• Partner with Lead Nurse and participate in CTRS in-service protocol meetings.
• Maintain required training, credentialing, competencies, and other requirements as specified by MSOM, UHT, JHS, and other relevant entities (including Citi Training, Bio Safety, Lab Safety, OSHA, and HIPAA).

8.Participate in quality review to ensure accurate and compliant documentation.

9.Reviews Serious Adverse Events documented and reported per the protocol and regulatory requirements for protocols serviced by the CTRS.

• Work closely with principal investigators and staff across multidisciplinary teams to ensure seamless protocol execution and high-quality patient care.
• Demonstrate knowledge and understanding of policies, procedures, and regulations governing human subject research.
• Implementation of clinical trial protocols requiring CTRS services, ensuring adherence to Good Clinical Practice (GCP), FDA, HIPAA, and IRB regulations.
• Assess and document protocol-related patient compliance and response to treatment according to physician treatment orders.
• Educate staff about protocols related to treatment, possible side effects, and complications.
• Enter research-related orders and results in UChart / Cerner as per protocol.
• Receive Investigational Products from Research Pharmacy and administer the drug according to physician treatment orders.
• Serve as primary contact for PIs, staff, and departments regarding protocol-related issues to ensure a safe environment for patients while maintaining compliance and adhering to regulatory guidelines.
• Assist in participant recruitment, screening, informed consent process, and retention efforts when required.
• Maintain a safe working environment by adhering to established policies and procedures within the unit.
• Ensure alignment with the University's strategic mission, vision, values, and Code of Business Conduct in planning research-related patient care and clinical research.

Department Specific Qualifications

• Bachelor’s degree in nursing (BSN) from an accredited Nursing school.
• Valid Florida Registered Nurse Licensure (RN)
• Basic Life Support Certification (BLS)
• Pediatric Advance Life Support (PALS)
• Advanced Cardiovascular Life Support (ACLS)
• Minimum 3 years of relevant experience in Nursing.
• Minimum 3 years clinical research experience.

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.

Job Status

Full time

Employee Type

Staff