Research Nurse

Nextonic Solutions is seeking a Research Nurse to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) located in Bethesda, Maryland.Qualifications:

• Nursing experience with CPR certification

• Master’s degree in nursing with current state licensure as a Registered Nurse.

• Experience working on clinical Protocols

• Strong diagnostic and clinical skills

• Excellent analytical, organizational and time management skills

• Strong verbal and written communication skills

• Experience with MedSurg Nursing

Statement of Work Details:

• Organize and facilitate the training program and teach physicians, physicians in training, nurses and other staff.

• Mentor health care members in the execution of trials and resolution of logistical constraints and update team members of changing directions in study implementation.

• Provide training to clinic staff regarding Investigator, brochure information, protocol implementation, general and specific data collection and research practices.

• Provide mentorship developing skills and expertise in research protocols and all aspects of clinical research.

• Provide mentorship to nurse specialists to develop skills and expertise in program areas.

• Recruits and screens patients for inclusion in protocols and clinical trials.

• Assist research and medical staff interview, screen and evaluate the appropriateness of eligible subjects for participation in the research protocol.

• Participate in recruitment and outreach activities and contribute to recruitment strategies through innovative ideas.

• Recruit and follow up with patients for clinical and basic research studies and protocols and provide clinical support to patients participating in protocol.

• Design and maintain a selection of materials appropriate to send to health care referral sources seeking eligibility information or other objectives.

• Organize and maintain an active referral list and master schedule for planning follow up and new patient admissions.

• 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 information about the study to referring physicians, advocacy groups, NIH offices, and in response to inquiries from potential study participants.

• 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.

• Obtain and record complete health histories and conduct physical assessments; communicate data from these and other sources.

• Manage clinical and research support activities to ensure patient safety and address the clinical needs of the patients.

• Review findings from assessments and other sources in clinical rounds.

• Review charts to collect relevant clinical data such as laboratory test results and social background.

• Complete medical and psychiatric assessments of potential participants in multiple research protocols by collecting and reviewing past and present medical records and conduct interviews with research applicants and their families.

• Conduct family interviews to obtain comprehensive understanding of the care needs of the patient.

• Continually assess ongoing understanding of the research process for patients and families and provide teaching and support as indicated.

• Administers protocol consents and documentation and monitors compliance.

• Ensure informed consent process and human subjects protection in clinical research and counsel patients regarding the potential risks.

• Collaborate with researchers and medical staff to obtain and maintain informed consent and assent and address ethical and legal implication of the research protocol.

• Contribute to all study related IRB and regulatory matters, including all reporting requirements (including deviations, unanticipated problems, adverse events) and report issues and variance promptly to the research team.

• Collect and report data to appropriate regulatory and monitoring agencies.

• Perform quality assurance and quality control activities relating to protocol adherence, protocol monitoring, data collection, data abstraction and data analysis and protect research participant data in accordance with regulatory requirements.

• Coordinate various activities to ensure proper and filing of serious adverse events, amendments, annual reports, and other regulatory documents.

• Prepare documentation and track and report regulatory and institutional protocol requirements and resolve all stipulations from protocol oversight groups.

• Performs data input and management.

• Perform accurate data entry into research database, including the use of standardized scales and assessments.

• Participate in data analysis and management as well as manuscript preparation and presentation of findings.

• Maintain computerized patient files and databases containing research data generated through protocol studies and perform data searches of medical records for analyses of patient characteristics.

• Support the general implementation, tracking, data acquisition, collection and reporting of all elements of the protocols.

• Manage data through research databases to ensure accurate and reliable data entry.

• Examine and monitor patients during protocol studies; ensure the collection of a complete clinical database on each patient.

• Provide expertise in clinical trial coordination and management of data acquisition.

• Performs clinical data interpretation and evaluates and interprets protocol and clinical trial findings.

• Document observations and identify and evaluate trends and important findings, communicating information to the multidisciplinary research team for prompt clinical action.

• Monitor activities pertaining to clinical protocols such as monitoring patient recruitment and retention, trial progress, and the need for extension or renewal of ongoing trials.

• 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.

• Develop intake tools and screening forms and work with researchers and medical staff on the general administration of protocols’ implementation.

• Collaborate with staff to analyze and evaluate current systems of health care delivery and to identify and implement new practice patterns.

• Participate in clinical practice and research support meetings and develop multidisciplinary performance improvement programs and projects to improve operating procedures, patient care and decrease costs.

• Problem-solve complex or unpredictable situations and improve processes and services to patients and colleagues. Participates in training and mentoring new staff.

• Develops new research protocols.

• Participate in the design and implementation of current and future protocols and studies.

• Survey the medical literature for background information on specific aspects of the diseases under purview.

• Design, implement and evaluate complex protocols and manage challenging patient populations and assist with document preparations and processes.

• Develop new standards for novel and unpredicted research situations and interventions.

• Utilize established resources to design new study methods to meet research study objectives.

• Work with staff on drafting of new protocol amendments and associated documents by providing editorial support and expert opinion.

• Perform protocol activities including study drug administration, data collection and submission, patient counseling and physical assessment.

• Maintain contact with patients and referring physicians to explain patient’s conditions and symptoms; interpret results of laboratory tests; discuss the future status of patients who have participated in the study.

• Interface with the inpatient and outpatient unit staffs to assess patient concerns and facilitate compliance with protocol studies.

• Examine and monitor patients during protocol studies; ensure the collection of a complete clinical database on each patient.

• Ensure that protocol and regulatory requirements are met in terms of patient safety and research goals.

• Participate in scheduled clinical update lectures at the LDB, branch meetings, clinical grand rounds and various relevant lectures.

• Respond to telephone inquiries from protocol patients regarding management problems; answer questions regarding patient medications, disease processes or health-related matters.

• Provide counseling and teaching for patients and their families as appropriate; direct inquiries to section chiefs or medical staff fellows if additional action is necessary.

• Act as liaison with Clinical Center nursing staff and the fellows/clinical associates in the Hepatology Training program.

• Perform preliminary review of patient referral and inquiries; obtain additional clinical and/or historical information as necessary based on research protocol criteria; direct information to the attending physician for action; work with physicians in writing letters to communicate with patients.

• Determine appropriate diagnostic testing in conjunction with medical staff.

• Stay abreast of the current therapeutics and clinical practices for patients with liver disease.

• Gather data for yearly IRB reviews; coordinate the submission process.

• Work with staff on prescheduling the appropriate evaluations, arranging patient travel and providing the patient with written confirmation of the appointment time and a list of the scheduled diagnostic testing.

• Schedule appropriate medical consultations as necessary.

• Participate in the weekly patient care conference; assemble diagnostic studies (x-rays and scans) for review at the conference.

• Attend professional meetings and seminars.

• Review and summarize relevant literature.

• Identify and implement ways to improve operating procedures, patient care and decrease costs.

• Work with staff on the recruitment and retention of patients into specific clinical protocols; ensure protocol compliance and database management.

• Implement clinical protocols.

• Educate patients regarding the nature of the disease process and possible therapeutic strategies and protocol objectives.

• Review charts to collect relevant clinical data such as laboratory test results and social background.

• Interview patients to obtain medical history, sexual history, medication history, history of use of substances such as alcohol and recreational drugs, previous HIV-related risk factors and history of participation in other clinical trials.

• Identify potential problems that may impede protocol implementation; determine if these problems need to be referred to the principal investigator for action or can be dealt with independently.

• Examine protocols regarding nursing support requirements and patient safety matters.

• Maintain computerized patient files and databases containing research data generated through protocol studies.

• Interpret data; identify results that merit prompt clinical action.

• Maintain required documentation and files for research protocols.

• Perform physical assessments of patients; analyze trends in patient conditions; suggest possible alterations in treatment regimens according to research protocols.