Sr Research Nurse - Broward Health - Onsite

Sr Research Nurse - Broward Health - Onsite (Full Time, Days)

Join Nicklaus Children's Health System as a Senior Research Nurse in Broward Health. The Senior Research Nurse is part of a central team of specialized research professionals within the Nicklaus Children's Hospital Research Institute (NCH-RI). This research position reports directly to the NCH-RI Clinical Trials Office (CTO) Manager and works closely with Lead CRAs, the Study Team (PI, Sub‑Is, CRCs, etc.),

NCH-RI departments, and Nicklaus Children’s Hospital administrators to ensure clinical research and related activities are performed in accordance with all applicable Federal regulations, NCH/NCH‑RI policies, and sponsor policies/requirements.

Key responsibilities include providing direction, support, and guidance to research clients and their families; developing and implementing educational activities pertaining to research, disease prevention, and care; assuring excellence in quality and protection of human subjects; assisting with research billing and compliance; coordinating team activities; and ensuring studies are carried out according to protocol, SOPs, and applicable guidelines and regulations.

• 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 workflows (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…