Administration/Operations

Research Nurse (Oncology)

Bethesda, Maryland
Work Type: Full Time

Research Nurse - this position will independently provide support services to satisfy overall operational objectives


Responsibilities:

  • Recruits and screens patients for inclusion in protocols and clinical trials.
  • Provide instruction to potential clinical study subjects and those involved in care of subjects on aspects of subject’s care, treatments, and side-effects.
  • Performs assessments and physicals, and collects medical histories.
  • Participate in direct patient care, in coordination with interdisciplinary team and specific team members to create and communicate a plan of care that balances clinical care needs with research.
  • Administers protocol consents and documentation and monitors compliance.
  • Collaborate with researchers and medical staff to obtain and maintain informed consent and assent and address ethical and legal implication of the research protocol.
  • Performs data input and management.
  • Perform accurate data entry into research database, including the use of standardized scales and assessments
  • Performs clinical data interpretation and evaluates and interprets protocol and clinical trial findings.
  • Present clinical data in terms which may be understood by the patient, as well as, interpretation at a level which is conversant with other health professional including physicians.
  • Participates in training and mentoring new staff.
  • Provide mentorship developing skills and expertise in research protocols and all aspects of clinical research.
  • Develops new research protocols.
  • Participate in the design and implementation of current and future protocols and studies.

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 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.
  • Monitor and support activities pertaining to clinical protocols such as monitoring patient recruitment and retention, trial progress, and the need for extension or renewal of ongoing 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 up and new patient admissions.
  • Collaborate with other members of the team in managing the patient’s progress throughout treatment
  • Obtain informed consent/assent 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, phone logs, screening logs, and regulatory binders, and accurate drug accountability records
  • Provide expertise in patient care coordination and implementation of protocol requirements 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

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.

Requirements:

  • Master’s degree in nursing
  • Oncology related experience with CPR certification
  • Experience producing reports, meeting minutes and organized presentations
  • Clinical Trial experience required
Agency / Institute:
NIH/NCI
 

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