Research Nurse II

Purpose
The Clinical Research Nurse is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). Assists with the execution of study-related activities of a Phase I clinical research study. Research nurses should primarily be concerned with the protection and care of research subjects. The primary role is to function as a licensed registered nurse engaged in the practice of care/assessments of the healthy volunteers and/or patient. Position includes disseminating information regarding new information for documentation, performance improvement and data source upgrades.

Responsibilities
" Review protocols and informed consent forms for scheduled studies, identify and communicate potential issues to the appropriate personnel.
" Participate in nursing study related activities as required by protocol compliance with Corporate, divisional, and departmental SOP s and external (CFR, ICH GCP) regulatory guidelines. Responsible for compliance with applicable Corporate and Divisional Policies and Procedures.
" Evaluate adverse events and manage safety reporting activities in a timely manner.
" Interact with the Principal Investigator and other study physicians, Recruiting/Screening, Data Systems, and other personnel in support of study-specific activities.
" Support quality and compliance improvement initiatives as appropriate.
" Participate in the recruitment and screening activities to ensure successful enrollment of volunteers into studies scheduled at the Phase 1 Unit. Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol. Review and assess data collected. Serve as a resource person or act as a consultant within area of clinical expertise (R/S).
" Disburses investigational drug and provides teaching regarding administration, as necessary. Develops accurate source materials and ensures compliance from site staff. Ensures all protocol procedures are completed per study requirements (Unit).
" Other tasks as assigned.

What are the top 3-5 skills, experience or education required for this position:
a. Required Skill 1: Communication skills
b. Required Skill 3: Customer Service skills
c. Required Skill 4: Multitasking
d. Required Skill 5: Nursing skills

EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.
e. Microsoft Office and Electronic Medical Record Platforms