We are currently searching for a Research Nurse to support Dr. Choi in conducting clinical research with human subjects at the NIH Clinical Center. The NIH Clinical Center policies require a research nurse to ensure the safety of human subjects involved in the clinical research. This is a part-time (24 hours/week), on-site opportunity in Bethesda, MD.
Duties & Responsibilities
- Assist research and medical staff interview, screen and evaluate the appropriateness of eligible subjects for participation in the research protocol.
- Manage clinical and research support activities to ensure patient safety and address the clinical needs of the patients.
- Ensure informed consent process and human subjects protection in clinical research and counsel patients regarding the potential risks.
- Perform accurate data entry into research database, including the use of standardized scales and assessments
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Document observations and identify and evaluate trends and important findings, communicating information to the multidisciplinary research team for prompt clinical action.
- 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.
- Organize and facilitate the training program and teach physicians, physicians in training, nurses and other staff.
- Provide training to clinic staff with regard to 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.
- 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.
- Work with staff on drafting of new protocol amendments and associated documents by providing editorial support and expert opinion.
- Bachelors degree in Nursing
- Credentials as Registered Nurse at Clinical Center
- CPR Certification
- At least 8 years of experience
- Clinical Skills
- Communication skills, both written and oral
- Experience in implementing clinical protocol
- CRIS Account
- ATV account with Clinical Center
Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.
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