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.
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