Clinical Research Nurse

Job Description

• 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 activities 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 hospital/department staff directly involved with the care/treatment of research patients.
• Works with 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 the hospital and research institute.
• 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 is responsible for the collection of blood samples (PK samples and others), 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.
• Communicates with the Sponsor or representatives regarding scheduling and facilitation of study monitor visits and facilitates communication between the organization and Sponsor or Sponsor’s Representatives.
• Provides protocol and study feasibility input to the Leadership and Study Start-up Team.
• Works with QI/QA team to ensure quality standards are being met and reports adverse events, and protocol deviations.
• Ensures compliance with 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.

Hard Skills

• Nursing
• Clinical Research
• Phase 1 Clinical Trials
• Adverse Event Reporting
• Specimen Collection
• Data Analysis
• Protocol Design

Soft Skills

• Team Coordination
• Risk Identification and Mitigation
• Training Implementation
• Patient Interaction
• Communication
• Quality Documentation