(Archived) Research Nurse

Research Nurse

Akahi Associates, LLC is seeking a highly qualified Research Nurse to work at our client site the National Institute of Neurological Disorders and Stroke (NINDS) in Bethesda, MD. This is a full-time position with benefits. 40 hours per week, Monday – Friday.

Ethical and Nursing Standards

• Perform clinical trial and clinical research study duties in accordance with standards of nursing practice and the Code of Ethics.
• Promote ongoing compliance with the key ethical con­cepts of respect for individuals, beneficence, and justice.
• Ensure that members of vulnerable and other special needs populations enrolled in clinical trials or clinical research studies are identified and that their rights are addressed.
• Maintain awareness of what constitutes falsification of data or other research misconduct. Adheres to Federal and NINDS requirements for re­search misconduct reporting.
• Adhere to conflict of interest regulations and NINDS-specific policies.
  • Demonstrate knowledge of professional health care practices of neurology, surgery, and medicine, experimental therapies and professional health care practices, the biomedical research process, support of participants on biomedical research protocols, and awareness of ethical issues.

Protocol Compliance

• Adhere to applicable Federal, State, and NINDS regulations, policies, and procedures related to clinical research.
• Comply with processes and procedures required by different types of sponsors and contractual partners (e.g., private industry, Federal agency, investigator).
• Contribute to discussions regarding feasibility of protocol implementation and execution with a specific focus on clinical issues, available resources, study coordination, participant safety, and data quality.
• Collaborate with PI’s to identify and resolve protocol implementation, design, and execution problems; use and participate in revising and creating data capture forms to meet study needs.
• Collaborate with principal investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for study drugs, biologics, and devices.
• Facilitate and participate in the preparation for and conduct of meetings with sponsors, collaborators, monitors, and auditors.
• Communicate with and participate in the interdisciplinary team to ensure protocol compliance and timeliness of protocol-related pro­cedures and visits; ensures proper use of and accountability for study drugs, biologics, and devices; identifies facilitators and barriers to protocol compliance; monitors for and responds to variances in participant protocol adherence and report them to research team.
• Provide education about specific protocols and process changes to clinical staff caring for participants on clinical tri­als and clinical research studies.
• Provide timely, accurate, and complete reporting of adverse events, unanticipated problems, deviations, viola­tions, noncompliance and regulatory reporting to the research team. Contributes to development of corrective and preventive action plans for unanticipated problems, deviations, viola­tions, and issues of noncompliance.
• Participate in communication of findings and suggestions to the PI; reporting of clinical data to regulatory and monitoring agencies; production of reports for clinical use and treatment decision-making; and summarization of clinical data as requested by PI’s.
• Contribute as a co-investigator on clinical trials and clinical research studies as well as various collaborative projects.

Informed Consent

• Identify and intervene to address facilitators and barriers to effective informed consent discussions and decision making (e.g., literacy, capacity, language, distress, lack of time, therapeutic misconception).
• Obtain confirmed informed consent/assent prior to the beginning of any studies or therapies.
• Describe and abide by all applicable policies and processes for informed consent, which includes, but not limited to ensuring that the most current version of the IRB-approved protocol consent document is used when consenting a participant, collaborating with the PI to ensure initial and ongoing consent process is performed and documented, and ensuring timely re-consenting as needed.
• Assess ongoing consent through discussions with participants and reinforcement of education.

• Assess participant’s understanding of the information provid­ed during the informed consent process.

Participant Recruitment and Retention

• Identify facilitators and barriers to recruitment and retention; work to address barriers to recruitment and retention; identify problems in referral process and in implementing strategies to handle problems.
• Respond to incoming participant-related inquiries from the general public and other health care professionals, regarding clinical research protocols.
• Identify and develop relationships with institutional or community-based resources or groups that can assist in achieving recruitment goals; participate in developing materials with input of PI(s) and IRB approval for referral sources outlining eligibility information
• Interview and evaluate all participants being screened for entry into clinical trials and clinical research studies.

Management of Research Participants

• Uses the nursing process to identify participant care needs in the context of the study design and needs beyond the clinical trial and clinical research study requirements and collaborate with other members of the healthcare team to ensure participant safety.
• Administers research interventions, as appropriate; collect participant data according to protocol specifications; evaluate participant's response to therapy.
• Assesses participant and families to ensure ongoing understanding of the research process; provide education and verbal responses to participant and family inquiries about protocols throughout the protocol lifecycle.
• Advocates for participants and families and support participants' rights.
• Serves as a communication liaison between interdisciplinary team and the research participant.
• Participates in the initial and ongoing assessment of study participant eligibility for a clinical trial and clinical research study, including documentation of criteria specified in the protocol.
• Assesses adverse events and ensures evidence-based symptom management as permitted by the protocol.

Documentation & Document Management

• Document, collect and record all participant encounters in the legal medical record per licensure and institutional requirements; obtain documents from outside providers or laboratories that are needed as a part of the research data.
• Participate in office and branch activities to improve documentation.

• Collect and record all applicable research information from the participant in the research record throughout the lifecycle of the study.
• Maintain the privacy and confidentiality of participants’ source documents.
• Document and retain all research-related records according to regulations, guidelines, and institutional specific policies, including ensuring good documentation practices for all documents.

Data Management and Information Technology

• Ensure that all data recorded on case reporting forms (CRFs) are complete and can be verified with­in the source documents; troubleshoot data entry issues whether CRF is paper or electronic.
• Participate in quality control activities to ensure data integrity, including timely responses to database or sponsor queries.
• Protect participant, protocol, and scientific confidentiality by ensuring security of research data and personal health in­formation.
• Enter data into electronic data capture systems, as appli­cable.
• Anticipate and consistently meet reporting deadlines, collaborate with PIs and teams to note data trends and identify problems; note trends in toxicities, participant information, and data collection points.

Leadership and Professional Development

• Attend educational/training activities to maintain a current clinical trial and clinical research study Good Clinical Practice (GCP) knowledge base.
• Serve as an expert resource to the client in a regularly changing field, and address identified knowledge and skill gaps related to role as nurse specialist (research).

DELIVERABLES. Upon request, the contractor shall provide documentation evidence of any and/or all work product, including, but not limited to, the following tasks:

• Work products and documents related to administering research interventions; collect participant data; evaluate participants’ response to therapy; obtain informed consent/assent; respond to and report variances in protocol implement: collect and record research information.

• Work products and documents related to managing conflicts/issues in clinical research families; assess participants and families; provide verbal responses to participants and families; respond to inquiries from the general public and health care professionals regarding clinical research protocols.
• Work products and documents related to preparing clinical laboratory and diagnostic test results; contribute to interdisciplinary team; participate in meetings; assess and communicate participant care needs.
• Work products and documents related to educating participants and families; perform individualized teaching; advocate and support participants’ rights; identify learning needs for practice environment; explore and communicate research issues.
• Work products and documents related to contributing to teams, workgroup processes; provide substantive outcomes; complete assignments within established timeframes.

CERTIFICATIONS, LICENSE, PHYSICAL REQUIREMENTS OR OTHER EXPERTISE REQUIRED. The contractor must have:

• Master’s degree in Nursing with current state nursing licensure; three (3) years of specialized experience plus a Bachelor’s degree is equivalent to a Master’s degree.
• Minimum of two (2) years of related experience.
• Demonstrated knowledge of professional health care practices of neurology, surgery and medicine, experimental therapies and professional health care practices, the biomedical research process, support of participants on biomedical research protocols, and awareness of ethical issues.
• Strong diagnostic and clinical skills.
• Strong communication skills, both oral and written.
• Excellent analytical, organizational and time management skills.
• Experience in collecting patient data; evaluate patients’ response to therapy; obtaining informed consent/assent; responding to and reporting variances in protocol implement.
• Experience in collecting and recording research information.
• Experience in managing conflicts/issues in clinical research setting; assessing patients and families; providing verbal responses to patients and families; responding to inquiries from the general public and health care professionals regarding clinical research protocols.
• Experience Data Management and Information Technology as related to case reporting forms (CRFs).

For further information, please click [Register to View] to view the EEO Is The Law poster. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status. Only qualified individuals who are being considered will be contacted for an interview.