- 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 coordinate 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.
Clinical Research Nurse Ph 1 - Miami, United States - Nicklaus Children's Health System
Description
Job Summary
The Phase 1 Clinical Research Nurse Coordinator 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 but works closely with Lead CRA's, Study Team (PI, Sub-I's, CRC', etc.), NCH-RI departments and Nicklaus Children's Hospital (NCH) department administrators, and other clinical research professionals to help ensure that clinical research and related activities are performed in accordance with all applicable Federal regulations, NCH/NCH-RI applicable policies and sponsor policies/requirements. This research position will also coordinate team activities to ensure studies are carried out according to protocol, standard operating procedures (SOPs) and applicable guidelines and regulations.
Job Specific Duties