Research Nurse Job at Akahi Associates, LLC
Overview:
Under this task order, the contractor will independently provide support services to satisfy the overall operational objectives of the National Human Genome Research Institute. The primary objective is to provide services and deliverables through performance of support services.
Full-time, 40 hours/week
The salary is starting at $95,000/year but is dependent on experience.
Statement of Work Details:
Overall Position Summary and Objectives:
Under this task order, the contractor will independently provide support services to satisfy the overall operational objectives of the National Human Genome Research Institute. The primary objective is to provide services and deliverables through performance of support services.
NHGRI is looking for a candidate that obtains a Master's degree in nursing. A bachelor's degree with at least 2 years of specialized experience in pediatrics is also acceptable for this position.
Full-time, 40 hours/week
Monday-Friday, no nights
The salary is starting at $95,000/year but is dependent on experience.
Benefits include: 80 hours PTO, 11 government holidays, healthcare benefits, dental, vision, etc.
Statement of Work Details:
- 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.
- Interview, screen and recruit patients for entry into protocol; contribute to conferences determining who will be accepted into the UDP. 1 initiate active efforts for protocol enrollment
- 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.
- Determine suitability of patients for travel.
- Communicates with families and caregivers to obtain medical records; conduct family interviews to obtain comprehensive understanding of the care needs of the patient and family members during travel to and from NIH and throughout the evaluation period.
- Serves as point of contact for families and their physicians; perform data retrieval; communicate test results to outside entities; ensure adequate consents.
- Respond to phone calls from patients or potential patients inquiring about specific diseases
- 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.
- Assist with and performs quality assurance and QC activities relating to protocol adherence, protocol monitoring, data collection, data abstraction and data analysis.
- Ensure that standard operating procedures (SOPs) reflect the highest standard of rigor.
- Assist with data through CRIS and UDPICs databases to ensure accurate and reliable data entry.
- Perform and/or coordinate the collection, processing and handling of laboratory samples, including appropriate storage and shipping.
- Serve and point of contact among laboratory personnel, families and phlebotomy services to ensure timely acquisition and receipt of samples.
- 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.
- Report data to appropriate regulatory and monitoring agencies and create database to capture forms to meet protocol needs.
- Facilitate the ease of reporting, avoidance of repetition of data entry procedures and generation of reports appropriate to various agencies.
- 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. adjust patient care in the absence of established guidelines. work with principal investigator to make recommendations to patients and families regarding disease management.
- Engage in team meetings to update team members of changing directions in study implementation.
- Perform data searches of medical records for analysis of patient characteristics
- Participates in training and mentoring new staff
- 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 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.
- Provide mentorship to nurse specialists to develop skills and expertise in program areas.
- Advise health care members in the execution of trails and resolution of logistical constraints; ensure that all aspects of
- Good Practice (GCP) and federal regulatory requirements are met/exceeded.
- Serves as a liaison between NIH and various outside agencies to further the mission of education and protocol implementation.
- 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.
- Develop intake tools and screening forms; work with staff on the general administration of protocols' implementation.
- Survey medical literature for background information on specific aspects of the diseases under purview.
- Other
- Interview, screen and recruit patients for entry into protocol; contribute to conferences determining who will be accepted into the UDP.
- Determine suitability of patients for travel.
- Communicate with families and caregivers to obtain medical records; conduct family interviews to obtain comprehensive understanding of the care needs of the patient and family members during travel to and from the NIH and throughout the evaluation period.
- Serve as point of contact for families and their physicians; perform data retrieval; communicate test results to outside entities; ensure adequate consents.
- Respond to phone calls from patients or potential patients inquiring about specific diseases.
- Adjust patient’ plan of care in the absence of established guidelines.
- Work with Principal Investigator to make recommendations to patients and families regarding disease management.
- Develop new standards for novel and unpredicted research situations and interventions.
- Provide on-call services to the multidisciplinary team, relevant to all matters of clinical research issues, for patients who are seen on-site.
- Provide mentorship to nurse specialists to develop skills and expertise in program areas.
- Provide in-services to inpatient and outpatient unit nursing staff; provide informal education to care providers.
- Advise health care members in the execution of trials and resolution of logistical constraints; ensure that all aspects of Good
- Clinical Practice (GCP) and federal regulatoryrequirements are met/exceeded.
- Design, implement and evaluate complex protocols; assist with challenging patient populations.
- Develop intake tools and screening forms; work with staff on the general administration of protocols’ implementation
- Serve as liaison between NIH and various outside agencies to further the mission of education and protocol implementation.
- Initiate active efforts for protocol enrollment.
- Collaborate with staff to obtain and maintain informed consent/assent and address ethicaland legal implication of same.
- Assist with and perform quality assurance and QC activities relating to protocol adherence, protocol monitoring, data collection, data abstraction and data analysis.
- Ensure that standard operating procedures (SOPs) reflect the highest standard of rigor.
- Assist with data through CRIS and UDPICS databases to ensure accurate and reliable data entry.
- Perform and/or coordinate the collection, processing and handling of laboratory samples, including appropriate storage and shipping.
- Serve as point of contact among laboratory personnel, families and phlebotomy services to ensure timely acquisition and receipt of samples.
- Engage in team meetings to update team members of changing directions in study implementation.
- Report data to appropriate regulatory and monitoring agencies; anticipate and create databases and data capture forms to meet protocol needs.
- Facilitate the ease of reporting, avoidance of repetition of data entry procedures and generation of reports appropriate to various agencies.
- Design and maintain a selection of materials appropriate to send to health care referral sources seeking eligibility information or other objectives.
- Perform data searches of medical records for analyses of patient characteristics.
- Survey the medical literature for background information on specific aspects of the diseases under purview.
- Problem-solve complex or unpredictable situations and improve processes and services to patients and colleagues.
- Participate in clinical practice and research support meetings; develop multidisciplinary performance improvement programs and projects.
- Collaborate with staff to analyze and evaluate current systems of health care delivery and to identify and implement new practice patterns
Deliverables:
- Work products and documents related to interviewing, screening and recruiting patients for entry into protocol; communicate with patients and caregivers to obtain medical records; conduct family interviews; perform data retrieval; ensure consents.
- Work products and documents related to developing new standards for research; provide on-call services; provide mentorship to nurse specialists and in-services to inpatient and outpatient staff; provide education to caregivers.
- Work products and documents related to the execution of trials; ensure that all aspects of GCP and other regulatory requirements are met or exceeded; design, implement and evaluate complex protocols and screening forms.
- Work products and documents related to obtaining and maintaining informed consent/assent; direct and perform quality assurance and quality control activities; manage databases to ensure accurate and reliable data entry.
- Work products and documents related to collection, processing, handling, storage and shipping of laboratory samples; engage in team meetings; report data to regulatory and monitoring agencies.
- Work products and documents related to designing and maintaining a selection of materials for health care referral sources; perform data searches of medical records; survey literature for background information; participate in support meetings.
Certifications & Licenses:
- Master’s degree in Nursing preferred
- Bachelor's degree with 2 years of specialized experience is also acceptable
- Current state nursing licensure
- CPR Certification
Field of Study:
- Nursing
Software:
- MS Office
Skills:
- Excellent analytical, organizational and time management skills
- Two (2) years of specialized experience plus a bachelor's degree is equivalent to a Master's Degree.
- Minimum of two (2) years of experience in Pediatrics.
- Expertise in matters related to the research process and specific, complex patients with undiagnosed diseases.
- Strong communication skills, both oral and written.
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