Job Department: Professional Services

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.

• 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

• Manage clinical and research support activities to ensure patient safety and address the clinical needs of the patients. 1 

• 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. 

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

The purpose of this position is to provide administrative support to research teams and participants enrolled in a National Institute of Allergy and Infectious Diseases protocol. The Patient Care Coordinator (PCC) will be responsible for all scheduling activities, including arranging appointments, travel and entering remuneration into appropriate systems. The PCC will need to communicate effectively with participants and teams related to scheduled activities, follow-up and the logistics of each appointment.

• Meet with lab members to present updates – Ad-Hoc
• Work products and documents related to performing logistical and administrative duties that facilitate participant travel and appointments by commutating with participant, caregivers, family members and staff while coordinating and planning simple and complex travel, lodging and transportation arrangements; acting as a point of contact between physicians, nursing, NIH staff, contractors and other departments; and acting as a point of contact between staff, departments and participants/caregivers/family members. – Ad-Hoc
• Work products and documents related to collecting outside medical documentation, electronically scan and upload records (including patient ID and demographic data) into the electronic medical record as appropriate, communicating with various clinical administrative support offices/clinics/employees concerning the obtainment of outside patient records – Ad-Hoc
• Work products and documents related to adapting and maintaining filing systems to create and support an ongoing data base of patient encounters and patient appointments; entering and updating clinic and/or physician appointment schedule availability into the central appointment calendar; and providing appointment and travel information to patients, including scheduled dates and times, appropriate documents to bring, clinic information, hospital maps, travel, and hotel information. – Ad-Hoc
• Work products and documents related to obtaining up-to-date patient records and other pertinent information prior to appointments or visits; and sending patient appointment reminders and travel details. – Ad-Hoc

• Coordinates the recruitment, scheduling, travel and admission of research study participants. 
• Coordinate the recruitment, scheduling, travel and admission of research study participants with clinical staff. 
• Work with staff to coordinate new research patient screening appointments, procedures and imaging studies between protocol investigators and the outpatient clinic scheduling personnel. 
• Coordinate scheduling, travel and lodging of subjects participating in studies. 
• Assess unique participant needs prior to visit and address needs with clinical team (i.e. interpreting services, assistive devices, isolation etc.). 
• Distributes recruitment materials. 
• Distribute patient recruitment and communication materials. 
• Acts as a liaison between participants, participant’s relatives and staff members and communicates participant’s questions, complaints, problems and concerns to appropriate staff members. 
• Triage questions to appropriate personnel in the team as necessary. 
• Maintain ongoing relationships with patients, families, caregivers, medical care providers and various individuals on a continuous long-term basis. 
• Explains policies and procedures to participants and refers them to appropriate staff. 
• Respond to communications with research subjects, direct questions to appropriate team member. 
• Stay current on Clinical Center and Institute communications. 
• Updates participant resources and educational materials related to their visit as needed based on these communications. 
• Keep participants informed of Clinical Center and NIH campus changes affecting their visit. 
• Collates, enters and maintains data collected on participants. 
• Collect outside medical documentation, electronically scans and uploads records into the electronic medical record. 
• Review medical records to collect relevant clinical data. 
• Maintain patient files, medical records, and patient family contacts, file medical record notes into patient charts daily. 
• Create reports/spreadsheets for tracking and scheduling of protocol patients. 
• Obtain medical information, imaging disks and pictures from applicants on an ongoing basis; file them with the records. Coordinates new patient referrals by obtaining pertinent information and forwarding it for review. 
• Refer prospective volunteers per study guidelines to the appropriate Institute contact person. 
• Obtain outside medical records, radiology studies, biopsy slides and submit to the respective departments at the NIH. Communicate with appropriate staff about intake and materials and submission of materials for review. 
• May assist in preparing credentialing packages. 
• Perform Quality Assurance reviews on credentialing records. 
• Monitors workflow and administers and revises processes to maintain and improve operations. 
• Work with staff to achieve optimum schedule and staff utilization; work with staff in problem solving for overlapping appointments.
• Review future scheduled cases to resolve potential conflicts or problems; monitor additional reports to ensure data validity. Troubleshoot scheduling issues to ensure maximum productivity of staff resources. 
• Monitor and identify areas of improvement in the clinic environment, clinical trial conductance in the outpatient setting, for patients, families and staff. 
• Participate in training other clinical staff on clinical operations. 
• Participate in quality improvement initiatives and maintenance of SOPs. 
• Mentors and trains staff on patient recruitment and coordination processes and procedures. 
• Assesses organizational need and develops training programs to improve accuracy and performance of patient coordination processes and procedures. 
• Mentors and coach’s patient coordinators. 

Certifications & Licenses:

• Basic CPR certification 

 

Field of Study:

• Miscellaneous Biology 
• Communications 
• General Business 
• Miscellaneous Business Medical Administration 
• General Medical and Health Services 
• Miscellaneous Health Medical Professions 

 

Software:

• MS Office Suites 
• Electronic Medical Record

 

Skills:

• Maintain client communication regarding data management project status and review key project questions with clients, working in a hospital setting.
• HCA Process, track, and validate data accurately and on time, in accordance with data processing and entry instructions.
• Perform data abstraction and data entry on several different protocols into multiple clinical research databases.
• Identify project specific reports and assist in the development of these reports.
• Public or Community Health.
• Patient/Family Education
• Travel Arrangements
• Knowledge of clinical protocols and medical terminology.
• Strong interpersonal skills and the ability to work effectively in a team environment.
• Strong organizational skills with the ability to successfully manage competing priorities. 
• On-site Visits
• Data Collection 
• Communications 
• Scheduling

The primary objective is to provide Executive level support to the ORWH Director and deliverables through performance of support services. The minimum level of education required for this position is a bachelor’s degree in business administration or a similar field.

• Work products and documents related to updating and maintaining staff calendars; co-ordinate meetings, meeting materials and parking stickers; schedule conference rooms and audiovisual equipment. – Ad-Hoc
• Work products and documents related to reviewing and tracking property; place procurement orders; coordinate property activities; submit Help Desk tickets; coordinate building maintenance, repairs and renovations. – Ad-Hoc
• Work products and documents related to preparing documents, including office correspondence, SOPs purchase requests and justifications, office supplies inventory and equipment. – Ad-Hoc
• Work products and documents related to the analysis of projects and associated work assignments; project plans and milestones; project deliverables and requirements; weekly accomplishments reports; lessons learned reports. – Ad-Hoc

• Provides executive expertise needed to coordinate, improve, and oversee the overall functioning of the office. 
• Draft, review and send communications on behalf of the Director of ORWH. 
• Respond to written communications and work collaboratively with team members. 
• Summarize the content of incoming materials, specially gathered information, or meetings to assist executive; coordinate the new information with background office sources; draw attention to important parts or conflicts. 
• Ensure that requests for action or information are relayed to the appropriate staff; decide whether executive level should be notified of important or emergency issues. 
• Answer and respond to phone calls, communicate messages information to the ORWH Director within 24 hours of receipt. 
• Maintain good communication with OD staff, Institutes, and Centers and outside constituents in order to be aware of last-minute changes. 
• Coordinates with and acts as back up to other program support assistants.
• Handle sensitive and confidential information. 
• Execute other duties as assigned with professionalism. 
• Ensure strict confidentiality of calendar information. 
• Coordinate the day-to-day office operation, including, but not limited to problem and conflict resolution, organization and prioritization of tasks. 
• Make recommendations to resolve problems that arise. 
• Schedules and maintains an accurate tracking system of all activities. 
• Ensure successful execution of projects and provide updates on project progress to the ORWH Director; ensure that assigned projects stay on task and reach their goals and objectives. 
• Stays abreast of and implements current regulations, policies and procedures, and updates staff on relevant information. 
• Maintain files according to the ORWH internal policies and principles. 
• Plans and completes various special projects. 
• Ensure that office phone trees are up-to-date and accurate and make updates to reflect arrival/departure of staff. 
• Maintain the office shared drive and common office calendars. 
• Provide parking stickers for visitors as needed and as directed.  
• Arrange office networking events and other outside functions. 
• Submit Help Desk tickets as needed to remediate IT or phone or other communications issues for senior level staff. 
• Perform a variety of complex, specialized support tasks on an ongoing and ad hoc basis. 
• Update and maintain the emergency contact information and staff listing as needed. 
• Arranges conferences and meetings and contacts attending professionals, makes travel arrangements, maintains complex schedules and calendars, and advises staff on the most effective method and format of presentations. 
• Confirm meetings via email message with each participant/their assistant with information on the date/time, location, purpose of the meeting and a list of other participants. 
• Send reminder notices for these meetings to participants the day prior to the meeting date. 
• Interact with patience and diplomacy at all times in the course of scheduling. 
• Generate agenda, record minutes, follow-up on action items for senior leadership meetings. 
• Make updates to MS Teams site as directed and needed. 
• Note commitments made by executives during meetings and facilitate implementation for staff. Coordinate trans-ORWH meetings as directed and needed. 
• Serves as Liaison to ORWH or other NIH staff on various projects as assigned. 
• Prioritize meeting requests using judgement and critical thinking to handle scheduling for the ORWH Director.
• Maintain calendars for senior level staff members.
• Apprise the ORWH Director of upcoming events and speaking engagements. 
• Consult with ORWH senior staff to determine appropriate participants for meetings. 
• Schedule and coordinate weekly, biweekly and monthly appointments, meetings, luncheons and conference calls for assigned leadership team members using the preferred meeting platforms. 
• Updates databases and spreadsheets and creates reports for management. 
• Develop, maintain and utilize various administrative databases, as needed.
• Set up and format spreadsheets to analyze information, as needed. 
• Create spreadsheets, word documents, slides and other documents for senior level staff. 
• Coordinate the printing and conversion of paper documents to electronic files. 
• Maintain organization of electronic files on shared.
• Develop and/or complete forms and prepare for staff’s signatures. 
• Maintains inventory and initiates purchase requests. 
• Oversee inventory of office supplies. 
• Prepare purchase requests, maintenance agreement and draft justification for government signature of needed office supply items. 
• Collaborate with administrative staff to ensure that all purchase requests are filled in a timely manner. Review all property assigned to senior level staff to determine that all equipment is accounted for and properly assigned. 
• Order office supplies and equipment for senior level staff. 
• Coordinate equipment maintenance and ensure that all commonly used machines are in working order and supplied with paper and toner.

Certifications & Licenses:

• Certified Administrative Assistant 

 

Field of Study:

• Business Management and Administration

 

Software:

• SharePoint 
• MS Office 
• Concur 
• Webex

 

Skills:

• Social Media
• Knowledge of the Federal Travel Regulation 
• Meeting Minutes/Summary Reports 
• Executive Level Support 
• Meeting Coordination 
• Travel Planning 
• Calendaring

Under this task order, the contractor will independently provide support services to satisfy the overall operational objectives of the National Center for Advancing Translational Sciences, Therapeutics Development Branch (TDB). The primary objective is to provide services and deliverables through the performance of support services.

• Upon request, the contractor shall provide documentation evidence of any and/or all work products, including, but not limited to, the following tasks:
  • 1) Work on products and documents related to scaling up and synthesizing APIs and intermediates; design and develop scalable synthetic routes; optimize synthetic steps; isolate and identify impurities.
  • 2) Work on products and documents related to producing research reports; generate reports to support technology transfer to CROs; conduct and write literature reviews; search chemical databases for journal articles, patents and related technologies; publish and present relevant projects.
  • 3) Work products and documents related to collaboration with the technology transfer office and external patent offices to provide the necessary information for filing patents in selected programs. – Quarterly
• Clean Equipment – Weekly
• Meet with lab members to present updates – Monthly

• Gather, analyze and interpret data; prepare summaries and reports. 4
• Search chemical databases for journal articles, patents and related technologies. 5
• Provides laboratory experience needed to assist in performing various chemical experiments and procedures.
• Perform chemical and biochemical reactions and appropriate analytical analyses.
• Perform analytical validation and testing of compositions.
• Utilizes and operates various complex laboratory machines and equipment.
• Perform general maintenance and upkeep of equipment and instrumentation.
• Troubleshoot and provide routine maintenance of the instruments and equipment.
• Monitor, troubleshoot and initiate or take corrective action to maintain instrument function and quality.
• Identify the cause of common problems and mistakes and make necessary repairs.
• Documents and analyzes results, produces detailed summaries and reports.
• Write papers and abstracts detailing research efforts and results for publication in peer-reviewed journals.
• Collect and review data; analyze and interpret data and results.
• Produce research reports and communicate results.
• Analyzes organic and inorganic compounds to determine chemical and physical properties, composition, structure, relationships between compounds, and reactions.
• Formulate chemistry plans for the development of soluble, potent, selective small molecule probes of biological function.
• Analyze samples using validated analytical methods for ongoing studies.
• Perform the total syntheses of target compounds.
• Manage bulk-synthesis, purification and formulation efforts for advanced testing in animal models.
• Perform chemical synthesis and optimization of small molecule probes for use in biological research.
• Perform organic synthesis of key materials (e.g., reference compounds and precursors for labeling).
• Perform organic synthesis in support of the medicinal chemistry program.
• Perform solid state analysis of target compounds
• Adds heat, light, energy or a catalyst to show changes in composition.
• Purify compounds by preparative chromatography from chemists.
• Provides laboratory experience needed to perform various complex chemical experiments and procedures.
• Perform bulk-synthesis, purification and formulation efforts for advanced testing in animal models.
• Perform analytical validation and testing of compositions.
• Prepares test solutions, compounds, and reagents and maintains necessary laboratory supplies.
• Prepare reagents and maintain an active inventory of all chemicals kept in the laboratory.
• Keep an active inventory of all chemicals kept in the laboratory.
• Schedules, tracks and reports analyses of experiments and procedures.
• Perform analytical validation and testing of compositions and report results.
• Maintain computer database for various records.
• Independently provides laboratory experience needed to perform various complex chemical experiments and procedures.
• Perform bulk-synthesis, purification and formulation efforts for advanced testing in animal models.
• Develop new analytical and separation techniques for the solution of scientific questions.
• Perform analytical validation and testing of compositions.
• Designs and optimizes chemical experiments and procedures.
• Develop and document new procedures.
• Develop novel chemistry methodologies and technologies that advance the field and make recommendations.
• Collaborate with staff to evaluate and/or develop new techniques.
• Develop and present plans for novel syntheses and approaches to new compounds.
• Develop experimental procedures and research protocols.
• Develop and present plans for novel syntheses and approaches to new compounds.
• Carry out scale-up of the chemical probes of interest for additional studies.
• Trains staff on new experiments and practices, operations and maintenance of instruments and equipment, safety practices, etc.
• Maintain and perform training on scientific instrumentation and equipment.
• Work with staff on all mandatory training and competency assessments.
• Coordinate safety training (e.g., CPR and fire extinguisher use).
• Work with facilities manager on evacuation procedures and drills.

Certifications & Licenses

• Good Manufacturing Practice (GMP)

 

Field of Study

• Chemistry

 

Software

• Powerpoint
• MS Project
• Outlook
• Excel
• Word

 

Skills

• Microscopy: Confocal, Electron, Multi-Photon, Fluorescence, Super-Resolution
• Nuclear Magnetic Resonance
• Thin-layer chromatography
• X-Ray Crystallography
• Manuscript writing
• Mass Spectrometry
• Spectrophotometry
• Thermal analytical technologies
• Chromatography technologies (HPLC, UPLC, GC, IC)
• Kilo Lab or pilot plant experience

The purpose of this position is to perform RNA and DNA extractions and quality control for Long-read sequencing.

• Clean Equipment – Daily
• Meet with lab members to present updates. – Weekly
• Run experiments and write up report with results. – Daily

• Plans, executes, and arranges laboratory experiments, new techniques and procedures; and performs laboratory techniques relating to scientific research. 
• Work with staff on performing various experiments and procedures related to Nanopore long-read sequencing of DNA and RNA samples.
• Operates laboratory machines and instruments; and prepares specimens and equipment for use. 
• Operate and maintain instrumentation for long-read sequencing of DNA and RNA samples.
• Performs sample management and storage. 
• Store new samples, update database, retrieve samples with proper authorization.
• Analyzes, documents and reports on all procedures performed. 
• Convey and discuss research results with team lab members. 
• Update and maintain written laboratory record of the work. 
• Collect and enter research data into laboratory notebooks and databases. 
• Draw conclusions about the results as related to the ability of the experiments to answer the questions posed. 
• Interpret results of initial analysis to reveal conclusions and shortcomings. 
• Collect data and prepare for analysis and interpretation.
• Maintains inventory of laboratory supplies. 
• Provide support for ordering reagents and equipment required for the laboratory.
• Cleans and sterilizes instruments, glassware and equipment. 
• Ensure that adequate clean inventory is available for immediate usage. 
• Plans execute and arrange laboratory experiments, new techniques and procedures; and performs laboratory techniques relating to scientific research. 
• Perform fundamental procedures required for research projects. 
• Perform routine experiments and tests, including tissue culture, cell separation, protein, and quantitative and qualitative analysis. 
• Follow established procedures and protocols; utilize aseptic technique to perform experiments. 
• Perform a variety of laboratory techniques and procedures. 
• Perform routine analysis and tests on specimens in the laboratory. 
• Perform experiments on samples according to protocols. 
• Perform routine experiments and tests; follow established procedures and protocols. 
• Maintains inventory of laboratory supplies and initiates purchase orders. 
• Inventory laboratory supplies and equipment, make recommendations and prepare purchase requests. Order and maintain laboratory supplies, reagents and equipment. 
• Performs routine equipment maintenance. 
• Perform laboratory maintenance tasks, including scheduling liquid waste container pickup. 
• Monitor and maintain contracts for laboratory equipment and monitor equipment performance and maintenance schedule. 
• Plans execute and arrange laboratory experiments, new techniques and procedures; and performs laboratory techniques relating to scientific research. 
• Perform library preparation of samples for long-read DNA and RNA sequencing 
• Provide a broad range of technical assistance to laboratory members.
• Analyzes, documents and reports on all procedures performed and produces detailed reports for use by senior staff. 
• Prepare reports and summaries; prepare data for presentation at laboratory meetings. 
• Collect, analyze and interpret data; prepare summaries and reports based on results and findings. 
• Performs advanced equipment maintenance. 
• Assist in troubleshooting and calibrating various laboratory equipment and instruments. 
• Trains staff in performing routine laboratory tests and procedures. 
• Train new laboratory members in the correct use of equipment, application of techniques and laboratory protocols. 
• Provide support to laboratory staff in establishing and optimizing SOPs and protocols for processing long-read data.
• Provides insights and expertise and recommends new strategies and approaches. 

Certifications & Licenses:

• Laboratory Technician

 

Field of Study:

• Biology 

 

Software:

• PowerPoint 
• MS Project 

 

Skills:

• DNA Extraction

The Fogarty International Center’s Division of Int’l Science Policy, Planning, and Evaluation (DISPPE) advises Fogarty leadership on science policy (legislative affairs, research priorities, partnerships), strategic planning, and evaluation. Within DISPPE is the Center for Global Health Studies – a hub for global health science and policy. The person will conceptualize and implement CGHS projects in addition to tasks related to DISPPE functions. This includes conducting formative research, consulting with experts, organizing workshops, forming relationships with partners and leading steering committees. The individual works collaboratively to produce peer-reviewed publications, training resources, communities of practice, toolkits, etc.