Clinical Research Study Nurse

Overview

Laulima Government Solutions, LLC, headquartered in Honolulu, Hawaii, is a Native Hawaiian Organization (NHO) owned business. A premier government services company, Laulima Government Solutions offers a full spectrum of solutions that improve the performance and operational effectiveness of our government and Department of Defense customers. Our mission synchronized solutions are designed to deliver exactly what our customers need, when they need it. From base and range operations to biomedical defense support to telecommunications and IT services, we deliver the exact talent, tools and technologies needed to meet mission requirements.

 

Laulima Government Solutions is seeking a Clinical Research Study Nurse. This position will be located at Camp Hovey near Seoul City, South Korea.

The Clinical Research Study Nurse’s duties and responsibilities include execution of a clinical protocol, monitoring clinical study for compliance with the FDA regulations, advising subordinate staff in performing their duties in support of clinical studies and assisting reports and regulatory file submissions.

Job Duties:

• Work involves organizing and executing a phase 3 clinical protocols to compare the safety and immunogenicity of two smallpox vaccines.
• Will provide direct nursing services (care) using the nursing process in support of a clinical research trial.  Provide direct patient care daily, using the nursing process in support of a clinical research trial.
• Ensure appropriate and accurate documentation of patient care in the medical record and in designated electronic case report forms and specific computer programs.
• Advise, perform, and instruct staff, research participants and/or others about protocol-specific procedures and treatments, equipment, policies, adverse medication reactions, and follow-up instructions appropriate to the research study.
• Perform and/or assist in participants’ briefings and screenings, to include obtaining of informed consent.
  Based on guidance from Lead Principal Investigator, Site Principal Investigator and Nurse Protocol Coordinator, will update research investigators of relevant issues, concerns, and progress of study.
• Assist research investigators in collecting study data and statistics.
• Assist PI in submitting annual Continuing Review Reports (CRRs)  and annual report for the study.
• Write and review Standard Operating Procedures (SOP) and Study Specific Procedures (SSP) and guidelines.
• Ensure that studies are implemented in full compliance with FDA Regulations and Guidelines, Good Clinical Practices (GCP) and Department of Defense (DoD) and Department of the Army (DA) regulations, guidelines, and practices.
• Quality Control (QC) of tracking and filing of all protocol laboratory test results and samples.
• QC the preparation of study charts, source documents, labels and laboratory and other test results.
• QC of test article (vaccine) accountability.
• QC of regulatory study file to include filing of necessary documents per protocol SOP, Food and Drug Administration (FDA) and DA requirements.
• Prepare regulatory files and study records for QA audits, monitoring, etc. and assists in responses to audits and monitoring visits.

Requirements:

• Required Education: Associate of Arts degree in nursing program at an accredited college.
• Must possess and maintain a license as a registered nurse in a state or US territory that license nurses.
• Have a current BLS certification
• Must be GCP (Good Clinical Practice) trained or willing to complete such training.
• Possess computer skills in the following computer software programs:  Microsoft Office/Word and Excel.
• Have completed HIPAA training and will comply with proper handling of proprietary information.
• Complete all Government training required for position and/or organization.

Clearance:

This position requires the candidates to be U.S. Citizens and a favorable NAC background investigation completed.

Laulima Government Solutions, LLC is a fast growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid vacation and sick time; and 10 paid holidays.

For additional information on Laulima Government Solutions, LLC, please visit www.laulimags.com.

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans.  We are proud to state that we do not discriminate in employment decisions on the basis of race, color, religion, sex, national origin or disability status.  If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees.