Job Department: Professional Services

Axle is seeking a Policy Analyst – Privacy Resource Center Support  to join our vibrant team at the National Institutes of Health (NIH) in Bethesda, MD. The purpose is to provide centralized privacy support services across the National Institutes of Health. Full-time contractors are required to implement and sustain a comprehensive privacy compliance program. Contractor support includes integration of privacy into system lifecycles, review and approval of privacy documentation, support for authorization activities, privacy risk assessments, breach response coordination, and development and implementation of privacy policies, training, and guidance. 

Responsibilities include 

– Research, analyze and evaluate data for policy information. 1 

– Prepare a variety of status reports, management summaries and briefing papers which identify problems, assess the overall condition of work completed or in progress, and outline issues, solutions and recommendations. 2

– Privacy Impact Assessments, supporting System of Records Notices, compliance with federal privacy laws and policies, and assisting with privacy requirements throughout the information technology procurement lifecycle. 

– Provides technical experience needed to analyze, develop and implement organizational policies and practices. 

– Provides technical advice to program staff regarding new policies and procedures. 

– Interpret requirements, analyze gathered information, verify facts, draw conclusions and prepare work products. 

– Performs research of issues pertaining to current policies, regulations and procedures, and prepares issuance to program staff on changes. 

– Work with staff on reporting requirements, including collecting information, collaborating with other offices and preparing written reports. 

– Assists with data collection. 

– Analyze and evaluate data for policy information. 

– Collects and analyzes data. 

– Analyzes and provides information on current policy issues. 

– Prepare background information, options and recommendations that are used to brief upper management. 

– Attends meetings to review and implement discussion items. 

– Attend meetings, workshops, and seminars on relevant topics; provide a summary of relevant proceedings. 

– Prepares reports, graphs, etc., for use by upper management. 

– Compile data and prepare graphs, slides and presentations. 

– Provides technical expertise needed to independently analyze, develop and implement organizational policies and practices. 

– Perform fact finding and review to assist in developing and implementing organizational policies and practices. 

– Analyzes and consults with upper management regarding current policy issues. 

– Prepare background information, options and recommendations that are used to brief upper management.

– Summarizes data and prepares and reviews reports, graphs, etc., for use by upper management. 

– Interpret, analyze and condense material from a variety of sources for presentation.

– Develops new policies that support organizational goals. 

– Prepare recommendations and alternative options based on knowledge and analysis of policy practices and procedures.

– Plan, lead, and attends meetings to review and implement discussion items. 

– Attend meetings, workshops, and seminars on relevant topics; provide a summary of relevant proceedings. 

– Prepares briefing materials and professional packages for upper management and provides recommendations for improvement.

– Provide privacy compliance support services, privacy risk assessments, Privacy Impact Assessments, System of Records Notices, breach 

 Certifications & Licenses 

– Preferred: Certification or other Privacy Program Certifications. 

– Bachelor’s Degree 

Software 

– MS Office Suite experience. 

– PowerPoint 

– SharePoint 

– Excel 

– Word  

Skills 

– Able to work in teams, Communications, Strong work ethic, Computer Skills, Detail Oriented, Interpersonal 

– Research conduct and compliance 

– Data collection 

– Policy briefs 

– Writing

Position Information:

To provide services and deliverables through performance of support services.

Additional Qualifications:

Certifications & Licenses

• Bachelor’s degree in Life Sciences or other related discipline.

Field of Study

• Miscellaneous Biology

• Communications

• General Business

• Miscellaneous Business Medical Administration

• General Medical and Health Services

• Miscellaneous Health Medical Professions

Software

• MS Office Suite

Skills

• Must be able to communicate clearly and concisely, both orally and in writing.

• Strong customer service focus

• Knowledge of clinical protocols and medical terminology

• Strong organizations skills with the ability to successfully manage competing priorities

• Resourcefulness in problem solving

• Strong interpersonal skills and ability to work effectively in a team environment

• Ability to efficiently compose correspondence, prepare reports from raw data, design, set up and maintain the electronic and paper filing system

• Experience scheduling patient appointments and/or travel arrangements and maintaining patient records as it relates to patient care arrangements

• Travel arrangements

Deliverables:

• Work products and documents related to performing logistical and administrative duties that facilitate patient travel and patient appointments by commutating with patients, 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 patients/caregivers/family members. – Ad-Hoc

• Work products and documents related to collecting outside medical documentation, electronically scans and uploads 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

Statement of Work Details:

• Mentors and coaches patient coordinators. – 1
• Develops training materials, job aids and instructions for use by patient coordinators. – 2
• Assesses organizational need and develops training programs to improve accuracy and performance of patient coordination processes and procedures. – 3
• Participate in quality improvement initiatives and maintenance of SOPs. – 4
• Monitor and identify areas of improvement in the clinic environment, clinical trial conductance in the outpatient setting, for patients, families and staff. – 5

• 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.

• 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.

• Respond to patient emails and phone calls; prioritize patient related issues into urgent, emergent and routine; triage the issues to the appropriate personnel in the team as necessary.

• Explains policies and procedures to participants and refers them to appropriate staff.

• Respond to communications with research subjects; direct questions to appropriate team member.

• Collates, enters and maintains data collected on participants.

• Collect outside medical documentation, electronically scans and uploads records into the electronic medical record.

• 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.

• Prepare and process all documents required for initiation of employment and clinical activities for new program trainees’ rotation to the program from other NIH institutes and/or outside institutions.

• 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.

• Mentors and trains staff on patient recruitment and coordination processes and procedures.

• Perform logistical and administrative duties that facilitate the work of physicians, nurses, social workers, and other members of the Clinical Center (CC) staff who provide patient care.

• Communicate with patients, caregivers, family members and staff while coordinating and planning simple and complex travel, lodging and transportation arrangements.

• Act as a point of contact between physicians, nursing, NIH staff, contractors and other departments.

• Act as a point of contact between staff, departments and patients/caregivers/family members.

• Answer incoming calls, e-mails, and otherwise remains responsive to queries and concerns related to core duties as described above in a timely manner.

• Collect outside medical documentation, electronically scans and uploads records (including patient ID and demographic data) into the electronic medical record as appropriate.

• Communicate with various clinical administrative support offices/clinics/employees concerning the scheduling and coordination of patient appointments.

• Arrange patient travel including NIH billed lodging, meal reimbursements and local transportation services.

• Adapt and maintain filing systems to create and support an ongoing data base of patient encounters and patient appointments.

• Enter/update clinic and/or physician appointment schedule availability into the central appointment calendar.

• Provide appointment and travel information to patients, including scheduled dates and times, appropriate documents to bring, clinic information, hospital maps, travel, and hotel information.

• Obtain up-to-date patient records and other pertinent information prior to appointments or visits.

• Send patient appointment reminders and travel details.

Position Overview

The Patient Care Coordinator will provide administrative, operational, and patient care coordination support for the HCS. The role includes coordinating consult appointments and procedures, communicating with patients and clinical teams, maintaining program and research records, supporting regulatory activities, and improving clinical workflows.

Responsibilities

• Serve as the primary administrative point of contact for referring providers, patients, caregivers, and clinical teams regarding hematology consult services.
• Coordinate patient scheduling, research participant recruitment, travel, and admissions with clinical staff; provide appointment instructions, directions, visit preparation information, and Clinical Center registration guidance.
• Maintain consult service calendars for appointments, conferences, fellow continuity clinics, educational sessions, on-call schedules, weekend and laboratory coverage, and consult fellow schedules.
• Coordinate multidisciplinary patient care meetings and facilitate communication among referring providers, consult teams, ancillary services, and laboratories; relay participant questions and concerns to appropriate staff.
• Coordinate clinical and research bone marrow procedures and specimen collection with referring teams, inpatient units, laboratories, and hematopathology.
• Maintain consult databases, scheduling logs, study records, and program files; enter and clean questionnaire data, conduct database queries, and track operational metrics.
• Prepare reports on consult activity, bone marrow procedures, turnaround times, and operational performance, and assist with developing dashboards and performance measures.
• Develop, prepare, and review research proposals, abstracts, posters, manuscript drafts, protocol documentation, patient calendars, teaching aids, study reports, and status updates.
• Develop, maintain, and review standard operating procedures (SOPs), workflow documents, scheduling guides, educational materials, reference manuals, and operational resources.
• Collect and maintain investigator qualifications, trial logs, safety reports, study applications, annual reports, and correspondence; track study requests, submissions, and protocol approvals.
• Prepare and submit protocol actions through the NIH Protocol Tracking and Management System and coordinate regulatory activities throughout the protocol lifecycle, from development through study closure.
• Prepare and review clinical data for monitoring agencies and regulatory submissions, including investigational new drug (IND) and investigational device exemption (IDE) safety reports, clinical study reports, amendments, and annual reports.
• Track and review adverse event files and prepare reports in accordance with Institutional Review Board (IRB) processes and policies.
• Support quality assurance activities and regulatory audit preparation, and ensure consult coordination complies with NIH policies, institutional procedures, Health Insurance Portability and Accountability Act (HIPAA) requirements, and applicable regulatory standards.
• Identify workflow inefficiencies and support improvements to scheduling, patient access, and operational performance.
• Coordinate orientation, onboarding, and credentialing activities for incoming fellows, residents, advanced practice providers, students, and other personnel; maintain onboarding checklists, personnel documentation, and clinical research training records.

Required Qualifications

• Bachelor’s degree in healthcare administration, health sciences, nursing, biology, or a related field; equivalent healthcare experience may be substituted.
• Minimum of 2–3 years of experience in patient care coordination, clinical operations, or healthcare administration.
• Proficiency with Microsoft 365 applications, including Outlook and Teams, and experience with electronic medical records.
• Knowledge of medical terminology.
• Ability to maintain confidentiality, exercise independent judgment, and support quality improvement and operational initiatives.
• Strong organizational, communication, critical-thinking, and problem-solving skills, with the ability to manage multiple priorities in a fast-paced environment.

Preferred Qualifications

• Experience in hematology and/or oncology.

Deliverables

• Meet with laboratory members weekly to present updates.

Position Overview

The Clinical Protocol Coordinator will provide specialized genetic counseling and psychosocial support to patients and families affected by inherited diseases. The role includes communicating medical and genetic information, assessing psychosocial needs, developing family pedigrees, facilitating genetic testing and specimen collection, and coordinating with genetic counseling organizations and patient support groups. The coordinator will also support clinical and translational research, regulatory documentation, data analysis, and quality improvement.

Responsibilities

• Communicate medical, genetic, and psychosocial information to patients and families, including recurrence risk assessments and family-planning options.

• Conduct initial psychosocial assessments and refer patients for continued care as appropriate.

• Construct family pedigrees, contact family members, assist with obtaining genetic specimens, and facilitate clinical and research molecular testing.

• Coordinate with genetic counseling organizations and patient support groups.

• Assist with behavioral and genetic counseling research and the preparation and execution of clinical and translational research protocols.

• Review medical and scientific literature, organize and analyze research data, prepare manuscripts, and present findings at internal conferences and national or international scholarly meetings.

• Develop, assemble, write, edit, and review study protocols, amendments, study reports, audit documentation, and standard operating procedures (SOPs).

• Prepare and submit documentation to regulatory bodies and coordinate regulatory activities throughout the protocol lifecycle, from development through study closure.

• Track study requests, submissions, protocol approvals, and regulatory activities; maintain study databases and conduct basic analyses.

• Prepare, review, and submit clinical data to monitoring agencies.

• Review adverse event files for accuracy and completeness and prepare reports in accordance with Institutional Review Board (IRB) processes and policies.

• Maintain master participant lists, update enrollment status, assign study identification numbers, and obtain demographic information.

• Support ongoing clinical quality control and recommend improvements to the integration and delivery of genetic services.

• Evaluate the impact of legislation, publications, reports, and other information on current and planned genetic counseling activities and recommend appropriate actions.

• Develop training plans and train staff on protocol submission procedures.

• Advise investigators on the documentation and approvals needed to initiate clinical studies based on the study type, location, and complexity.

• Brief laboratory personnel on emerging genetics and genetic counseling issues and recommend responses.

Required Qualifications

• Master’s degree in genetic counseling.

• Certification or board eligibility as a Genetic Counselor through the American Board of Genetic Counseling (ABGC).

• Ability to be credentialed by the NIH Clinical Center.

• Knowledge of patient privacy, privileged information, and secure handling of medical records.

• Proficiency with Microsoft Office.

Deliverables

• Perform validation activities monthly.

• Inspect equipment biweekly.

• Meet with laboratory members biweekly to present updates.

Position Overview

The Pulmonary Function Technician will perform pulmonary function and exercise testing to generate physiological data for NHLBI research. The role involves working with adult and pediatric patients, monitoring patient responses, maintaining testing equipment, supporting quality assurance, and documenting clinical information.

Responsibilities

• Perform pulmonary function testing, including measurements of lung volumes and airway resistance by body plethysmography, impulse oscillometry, methacholine bronchoprovocation testing, and exhaled nitric oxide measurements.

• Conduct cardiopulmonary exercise tests and six-minute walk tests and collect arterial blood gases while supporting patient safety and comfort.

• Review testing orders and verify completion of pre-study administrative procedures.

• Monitor physiological responses during testing and therapy, consult a physician when adverse reactions occur, and provide first aid as needed.

• Assist in developing standard operating procedures for pulmonary function and exercise testing.

• Set up, calibrate, maintain, and troubleshoot diagnostic instruments and testing systems to support safe, reliable operation.

• Perform equipment quality checks, work with technical support to resolve issues, and assist with development and maintenance of a comprehensive quality assurance database.

• Train staff, trainees, and other healthcare personnel in testing procedures and the operation of laboratory instruments, equipment, and software.

• Document pertinent clinical information in patient electronic medical records and maintain accurate research and testing records.

• Analyze and interpret research data with laboratory staff and contribute to reports, presentations, posters, and manuscripts.

• Coordinate instrument scheduling and priorities with Principal Investigators and contribute to planning for laboratory resource needs.

• Mentor coworkers, identify training needs, and contribute to quality improvements in laboratory and clinical workflows.

• Protect confidential clinical information and research data in accordance with applicable privacy and data-safeguarding requirements.

• Maintain necessary licensure and current knowledge of relevant clinical policies and technologies.

Required Qualifications

• Master’s degree in biology.

• Valid Basic Life Support (BLS) provider card and either an Advanced Cardiovascular Life Support (ACLS) or Pediatric Advanced Life Support (PALS) card.

• Demonstrated clinical skills in pulmonary function testing and working with adult and pediatric patients.

• Experience with quality assurance testing, data collection, and equipment troubleshooting and maintenance.

• Proficiency with Microsoft PowerPoint and Outlook.

Deliverables

• Perform validation activities monthly.

• Inspect equipment as needed.

• Meet with laboratory members weekly to present updates.