(ID: 2024-6909)
Axle is a bioscience and
information technology company that offers advancements in
translational research, biomedical informatics, and data
science applications to research centers and healthcare
organizations nationally and abroad. With experts in
biomedical science, software engineering, and program
management, we focus on developing and applying research
tools and techniques to empower decision-making and
accelerate research discoveries. We work with some of the
top research organizations and facilities in the country
including multiple institutes at the National Institutes of
Health (NIH).
Axle
is seeking a
Research Nurse Specialist to join our vibrant team at the National Institutes of Health (NIH) supporting the Clinical Center (CC) located in Bethesda, MD.
Benefits We Offer:
- 100%
Medical, Dental & Vision Coverage for Employees - Paid Time Off and Paid Holidays
- 401K match up to 5%
- Educational
Benefits for Career Growth - Employee Referral Bonus
- Flexible
Spending Accounts:- Healthcare (FSA)
- Parking
Reimbursement Account (PRK) - Dependent
Care Assistant Program (DCAP) - Transportation
Reimbursement Account (TRN)
Overall Position Summary and Objectives
This Research Nurse position supports TBHD Branch at the NIH Clinical Center in Bethesda, MD. Provides expertise in protocol coordination and implementation, data and study management. Assures all aspects of GCP, ICH, and Code of Federal Regulations are met/exceeded. Manages research support activities to assure patient safety, study integrity, and accurate data collection. Supports biomedical research through detailed observations, measurements, and data collection related to pertinent assessments as defined by the study specifications and use of expert clinical judgment. Periodically (roughly 9 Saturdays in 12-month period) travel off-site into community to assist TBHD.
Deliverables:
- Administers research interventions accurately and precisely – Daily
- Collects patient data according to study specifications – Daily
- Provides timely verbal and written feedback to PI and research team related to all issues affecting quality of research endeavor – Daily
- Research Nurse Specialist provides training to less experienced team members resulting in their ability to complete delegated tasks. – Ad-Hoc
- Develops, prepares and submits relevant documents for IRB submission and related monitoring visits – Ad-Hoc
Work Details:
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Manage clinical and research support activities to ensure patient safety and address the clinical needs of the patients. 1
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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. 2
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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. 3
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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. 4
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Assists Investigator and study team with the execution of clinical trials and assures that all aspects of Good Clinical Practice (GCP) and federal regulatory requirements are met/exceeded. 5
- 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.
- 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.
- Assists with the collection, processing and handling of laboratory samples including appropriate storage and shipping as needed. Periodically travel “off-site” (off the NIH Bethesda campus) into the community to assist TBHD research team with protocol planning, recruitment, and implementation activities. Most off-site activities would occur on a Saturday, not more than 9 times in 12 months. 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. problems, adverse events) and report issues and variance promptly to the research team. Collect and report data to appropriate regulatory and monitoring agencies.
- 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.
- Prepares for and coordinates site visits made by sponsors or study monitors during the course of and at the close of the study. 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.
- 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.
- 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.
- Problem-solve complex or unpredictable situations and improve processes and services to patients and colleagues.
- Participates in training and mentoring new 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.
- Identify research activities post-bac and post-doc students can assist with and train accordingly.
- Develops new research protocols.
- Participate in the design and implementation of current and future protocols and studies.
- 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.
- Work with staff on drafting of new protocol amendments and associated documents by providing editorial support and expert opinion.
1, 2, 3, 4, 5 represents
priority rankings, where 1 is highest priority and 5 is
lowest priority of those ranked
Minimum Education
Associate
Additional Qualifications:
Certifications & Licenses:
- Registered Nurse
Field of Study
- Nursing
Software:
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
Skills:
- Proficient in conducting research tasks per regulations and guidelines such as GCP and CFR.
- Superior Organization Skills
- Complex Multi-Tasking of Research Activities
- Advanced Communication Skills
Disclaimer:The
above description is meant to illustrate the general
nature of work and level of effort being performed
by individuals assigned to this position or job
description. This is not restricted as a complete
list of all skills, responsibilities, duties, and/or
assignments required. Individuals may be required to
perform duties outside of their position, job
description or responsibilities as needed.
The diversity of
Axle’s employees is a tremendous asset. We are firmly
committed to providing equal opportunity in all aspects of
employment and will not tolerate any illegal discrimination
or harassment based on age, race, gender, religion, national
origin, disability, marital status, covered veteran status,
sexual orientation, status with respect to public
assistance, and other characteristics protected under state,
federal, or local law and to deter those who aid, abet, or
induce discrimination or coerce others to discriminate.
Accessibility: If
you need an accommodation as part of the employment process
please contact: careers@axleinfo.com