Sr. Clinical Research Nurse (Full Time, Days)

Nicklaus Children's Hospital•Miami, FL

About The Position

The Sr. Clinical Research Nurse, CTO is part of a central team of specialized research professionals within the Nicklaus Children's Hospital Research Institute (NCH-RI). The position reports directly to the NCH-RI Clinical Trials Office (CTO) Manager and works closely with Lead CRAs, study teams, NCH-RI departments, Nicklaus Children's Hospital department administrators, and other clinical research professionals. The role helps ensure clinical research activities comply with applicable federal regulations, NCH/NCH-RI policies, and sponsor requirements, and coordinates team activities so studies follow protocols, SOPs, applicable guidelines, regulations, and budgets. The nurse plans and coordinates study logistics, procedures, resources, training, and risk mitigation. The position provides and coordinates nursing care for clinical trial participants, supports recruitment and protocol compliance, and coordinates collection and analysis of study data and biological specimens. The nurse also supports regulatory and quality processes, study feasibility, sponsor communications and monitoring visits, research documentation, presentations, and local investigator-initiated study protocol development and amendments.

Requirements

Bachelor of Science in Nursing (BSN).
Active, good-standing RN licensure in Florida or a Multi-State Enhanced Nursing License Compact (eNLC) license, maintained throughout employment.
Complete the CITI course “Shipping and Transport of Regulated Biological Materials” for IATA certification within 3 months of hire.
American Heart Association PALS certification required within 6 months of hire and maintained active and in good standing throughout employment.
American Heart Association BLS certification, maintained active and in good standing throughout employment.
2–4 years of professional research or healthcare experience.
1–3 years of Phase 1 clinical research experience.
In-depth knowledge of Phase I clinical trials.
Demonstrated knowledge of clinical research trial design and execution.
Experience with electronic medical records and clinical trial management software applications.
Strong written and verbal communication skills.
Excellent interpersonal skills.
Excellent problem-solving skills.
Effective organizational and project management skills.
Ability to pay close attention to detail.
Ability to comprehend professional and scientific journals.
Ability to apply principles of logical and scientific thinking to a wide variety of intellectual and practical problems.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Proficiency in Microsoft Office, including Access, Word, Excel, Outlook, and PowerPoint.
Willingness to work off-hours depending on study requirements.

Nice To Haves

Advanced Registered Nurse Practitioner (ARNP) qualification.
Clinical research certification, such as CCRC, CCRP, or CRA.
Bilingual in English and Spanish.
Pediatric nursing experience in an acute care setting.
Experience in neurology, neurosurgery, or oncology.
Experience with database management tools and/or REDCap.

Responsibilities

Coordinate team activities to ensure studies follow protocols, SOPs, applicable guidelines and regulations, and budgets.
Plan logistics for protocol procedures, ensure thorough resource planning, identify study risks, and implement mitigation actions.
Prepare and deliver study-specific training materials, documents, and records, and coordinate training, dry runs, simulations, and tests as required.
Implement, monitor, and assess training programs to maintain staff proficiency, including annual validation and currency of required certifications and licenses.
Provide protocol-specific training to research study teams and hospital or department staff involved in the care or treatment of research patients.
Assist with developing, updating, and implementing research SOPs, guidance documents, standard work, and workflows related to early-phase research.
Coordinate, plan, implement, and evaluate nursing care for clinical trial participants, including adverse event reporting and other support activities.
Provide nursing-related care to study participants as outlined in applicable study protocols.
Coordinate and execute collection, compilation, and analysis of clinical research data from studies conducted by investigators and study teams at Nicklaus Children's and NCH-RI.
Interact with patients and families to recruit study subjects and ensure compliance with protocol and regulatory agency requirements.
Attend and participate in investigator meetings, pre-study visits, study initiation meetings, and coordinator meetings; produce quality documentation and complete assessments on time.
Coordinate and be responsible for collecting blood samples, cultures, tissues, and other specimens required by protocol.
Prepare oral presentations, written reports, and data requests describing research progress and trends, with appropriate recommendations or conclusions.
Communicate with sponsors or their representatives about scheduling and facilitating study monitor visits and facilitate communication between the principal investigator and sponsor representatives.
Review protocols and provide study feasibility input to NCH-RI Leadership and the Study Start-up Team.
Work with the QI/QA team to ensure quality standards are met and report adverse events and protocol deviations.
Ensure general and study-specific regulatory processes comply with SOPs, FDA and NIH requirements, and applicable regulations for reporting events to regulatory agencies.
Assist with designing and implementing protocols and forms or questionnaires, and preparing protocol amendments or study design modifications for local investigator-initiated studies.