Research Nurse Job at Akahi Associates, LLC

Akahi Associates, LLC Bethesda, MD 20814

Overview:
Overall Position Summary and Objectives

This position will independently provide support services to satisfy the overall operational objectives of the NCI/DCTD.

Weekly Hours:
  • 30 to up to 40 hours per week
  • Part-Time Position
  • Monday-Friday; No weekends
  • No set schedule
  • No work on Government Holidays
  • No nights
Responsibilities:
Deliverables
  • Work products and documents related to providing expertise in patient care coordination and implementation of protocol requirements during onsite visits; assist in the preparation and implementation of study protocols.
  • Work products and documents related to recruiting and evaluating clinical study subjects, scheduling appointments and interviews; provide instruction to potential clinical study subjects and those involved in care of subjects on aspects of subject’s care, treatments, and side-effects; provide patient education for protocol participants to ensure patient safety and protocol adherence.
  • Work products and documents related to monitoring and supporting activities pertaining to clinical protocols; coordinate various activities to ensure proper and timely filing of serious adverse events, amendments, annual reports, and other regulatory documents
  • Work products and documents related to preparing IRB documentation; completing all source documentation and Case Report Form; maintain thorough and organized study documentation; ensure that all aspects of Good Clinical Practice (GCP) are met or exceeded.
Other
  • Utilize established resources to design study methods to meet study objectives
  • Work with staff to coordinate and collect epidemiologic, genetic and clinical data
  • Participate in an interdisciplinary team supporting clinical evaluation and follow up
  • Provide instruction to potential clinical study subjects and those involved in care ofsubjects on aspects of subjects care, treatments, and side-effects
  • Provide patient education for protocol participants to ensure patient safety and protocoladherence
  • Monitor and support activities pertaining to clinical protocols such as monitoring patientrecruitment and retention, trial progress, and the need for extension or renewal ofongoing trials
  • Coordinate various activities to ensure proper and filing of serious adverse events,amendments, annual reports, and other regulatory documents
  • Support the collection, data entry, and assistance with special procedures for patients
  • Organize and maintain an active referral list and master schedule for planning follow upand new patient admissions
  • Collaborate with other members of the team in managing the patients progress throughout treatment
  • Obtain informed consentassent as needed
  • Collaborate with other members of the team for the collection, processing, and handling of research and clinical laboratory samples inside and outside of NIH
  • Ensure that all aspects of Good Clinical Practice GCP are met or exceeded
  • Complete all source documentation and Case Report Form
  • Maintain thorough and organized study documentation, including research records, phonelogs, screening logs, and regulatory binders, and accurate drug accountability records
  • Provide expertise in patient care coordination and implementation of protocolrequirements during onsite visits
  • Work with staff on the preparation and implementation of study protocols
  • Recruit and evaluate clinical study subjects, scheduling appointments and interviews
  • Prepare IRB documentation, including: initial submissions, protocol amendments,protocol modifications, Adverse
  • Event Reports, protocol deviations, protocol violations,continuing review, and informed consent documents
Qualifications:
Certifications, Licenses, and Experience:
  • Master’s degree in nursing -
  • Minimum of two (2) years of Oncology related experience
  • CPR certification
Field of Study:
  • Nursing
Software:
  • MS Office Suite
Skills:
  • Excellent analytical, organizational and time management skills
  • Ability to multitask, take initiative, pay attention to detail and work independently -
  • Strong communications skills, both oral and written
  • Experience working with Oncology Patient
  • Experience producing reports, meeting minutes and organized presentations.



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