Sr. Research Nurse - Cancer Institute - Ft. Lauderdale

Nicklaus Children's•Miami, FL

2d•Onsite

About The Position

The Senior Research Nurse is a specialized research professional within the Nicklaus Children's Hospital Research Institute (NCH-RI). This role reports to the NCH-RI Clinical Trials Office (CTO) Manager and collaborates with various teams including Lead CRAs, Study Teams (PI, Sub-I's, CRC's), NCH-RI departments, and Nicklaus Children's Hospital (NCH) department administrators. The primary focus is to ensure clinical research activities comply with federal regulations, NCH/NCH-RI policies, and sponsor requirements. The position involves providing direction, support, and guidance to research clients and their families, developing educational programs on research, disease prevention, and care, and ensuring excellence in quality, human subject protection, and information management. The Senior Research Nurse will also assist the Regional Research Manager with research billing and compliance, and coordinate team activities to ensure studies adhere to protocols, SOPs, and applicable guidelines and regulations.

Requirements

Bachelor's Degree in Nursing
Registered Nurse Licensure within the State of Florida or Multi-State Enhanced Nursing License Compact (eNLC) – maintain active and in good standing throughout employment
IATA certification completion required within 3 months of hire date
American Heart Association ACLS certification required within 3 months of hire date - maintain active and in good standing throughout employment
American Heart Association PALS certification required within 6 months of hire date - maintain active and in good standing throughout employment
American Heart Association BLS - maintain 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

Nice To Haves

APRN highly preferred.
Clinical research certification (e.g., CCRC, CCRP, CRA) preferred.
Bilingual in English/Spanish preferred.
Pediatric nursing experience in an acute care setting preferred.
Experience in neurology, neurosurgery, or oncology preferred.
Experienced with database management tools and/or REDCap preferred.
In-depth knowledge of Phase I clinical trials.
Demonstrated knowledge of clinical research trial design and execution.
Experienced with electronic medical record 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.
Willing and available to work off-hours depending on the study requirements.

Responsibilities

Coordinates team activities to ensure studies are carried out according to protocol, standard operating procedures (SOPs) applicable guidelines and regulations, and within budget.
Plans logistical activity for procedures as per protocol and ensures thorough resource planning.
Identifies risks on study and ensures that actions are implemented to mitigate risks identified.
Ensures study specific training materials, documents, and records are prepared and delivered or coordinates training, dry runs, simulations and tests as required.
Implements, monitors, and assesses the need for training programs to maintain staff skill proficiency, including annual validation and currency of required certifications and licenses.
Provides protocol-specific training to research study team and NCH hospital/department staff directly involved with the care/treatment of research patients.
Works with NCH-RI staff to assist with developing, updating and implementing new Research Standard Operating Procedures, guidance documents, standard work and work flows (related to early phase research).
Coordinates, plans, implements, and evaluates nursing care to clinical trial study participants including but not limited to Adverse Event reporting and other support activities.
Provides nursing-related care to clinical trial study participants as outlined (and applicable) in the study protocol.
Coordinates and executes the collection, compilation, and analysis of clinical research data from studies conducted by PIs and study teams at Nicklaus Children’s and the NCH-RI.
Interacts with patients and families to recruit study subjects and ensures compliance with protocol guidelines and requirements of regulatory agencies.
Attends and participates in investigator meetings, pre-study visits/initiation or coordinator meetings.
Produces quality documentation, including completion of assessments within the specified time.
Coordinates and responsible for the collection of blood samples (PK samples and other), cultures, tissues and other specimens as required by protocol.
Prepares oral presentations/written reports/data requests describing progress, trends and appropriate recommendations or conclusions as it relates to research at Nicklaus.
Communicates with the Sponsor or representatives regarding scheduling and facilitation of study monitor visits and facilitates communication between PI and Sponsor or Sponsor’s Representatives.
Reviews protocol and provides study feasibility input to the NCH-RI Leadership and Study Start-up Team.
Works with QI/QA team to ensure quality standards are being met and reports adverse events, protocol deviations.
Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies.
Assists with the design and implementation of protocols, forms/questionnaires and the preparation of amendments to protocols and/or modifications to study design as appropriate for local, Investigator Initiated studies.