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
30+ days ago