Duties

Cancer Center and LPOP Project Management and Support

• Independent management of all protocol regulatory related deliverables for industry, cooperative group, local investigator initiated, and consortia protocols conducted at the McGuire Cancer Center VAMC.
• Coordination of IRB, sponsor and other regulatory approvals for initial protocols and all amendments.
• Preparation and submission of new protocols to the IRB and other regulatory agencies.
• Independent interpretation of institution and federal policy guidelines.
• Independent preparation and review of all informed consents, patient information sheets and advertisements.
• Attend meetings with Principal Investigator, research team, affiliate staff and sponsors as necessary at team / sponsor.
• Distribute protocol updates from NCI research bases, industry sponsors, other VA Institutions and local investigators.
• Maintain audit ready hard copy and electronic regulatory "binders" to include all generally recognized regulatory essential documents.
• Track status of each assigned protocol at all times via sponsor websites, emails, and weekly broadcasts and ensure Principal Investigator and research team are aware of significant changes to protocol.
• Identify specific areas and processes for improved regulatory compliance.
• Maintenance and timely submission of investigator files, laboratory certifications, IRB rosters, investigator brochures and other protocol specific documents.
• Prepare and attend sponsor audits, respond to auditor questions while on site and take lead in preparing response to subsequent regulatory findings, post-audit.
• Attend, participate and/or coordinate study initiation, start-up, monitoring and close-out visits as required per sponsor, Principal Investigator and/or study team

Manages Data Collection and Analysis

• Participates in initial classification and coding of qualitative data and enters coding data into qualitative software.
• Recruits human research subjects based on eligibility criteria from Computerized Patient Record System (CPRS) or other database sources, performing medical record abstractions and maintaining tracking databases to chart study progress.
• The incumbent assists in the organization of data collection processes, statistical analysis and data management, summarizing research data through the use of computerized programs such as Microsoft Office, WORD, Excel, ACCESS.
• The incumbent audits research study records for compliance with Research and Development and Institutional Review Board (IRB) standards/requirements.
• Responsible for gathering data, submitting reports, and responding to inquiries from the National LPOP leadership team and members of the Cancer Center Research Program.
• The incumbent performs data analysis for program evaluation purposes and employees results to continue successful program development and enhancements.
• Requires skills identifying viable strategies using experience and insight to interpret data. In addition, the incumbent uses sound judgment in interpretation of trends and patterns; the application of guidelines; and recommendations for program augmentations.
• The incumbent oversees the development and management of data to evaluate program effectiveness and quality assurance and is responsible for developing program reports.
• The incumbent promotes enhancements to address challenges and unmet needs.

Perform Analysis and Evaluation of Healthcare Delivery Systems

• The incumbent conducts analytical studies on operational process, issue topics or related special projects as they relate to cancer care, utilization of molecular or other testing related to precision oncology, lung cancer screening, and cancer treatment.
• These studies would require statistical measurement, data analysis, and report preparation and development.
• When tasked with these types of projects, serve as the responsible contact for leading these projects from initiation to completion and may be required to present the results to senior leadership.
• The incumbent develops decision documents, analysis, action plans, and process flow maps on a variety of issues of technical complexity that cuts across multiple areas of the health care systems including radiation oncology, medical oncology, pulmonary, surgery, pharmacy, fiscal, nursing, radiology, and ancillary cancer services.

Performs other duties as assigned

Work Schedule: Monday through Friday, 8:00 am - 4:30 pm
Telework: This position may be authorized for telework. Telework eligibility will be discussed during the interview process.
Virtual: This is not a virtual position.
Position Description/PD#: Research Health Science Specialist/PD014120
Relocation/Recruitment Incentives: Not Authorized
Financial Disclosure Report: Not required

Requirements

Conditions of Employment

• You must be a U.S. Citizen to apply for this job
• Selective Service Registration is required for males born after 12/31/1959
• You may be required to serve a probationary period
• Subject to background/security investigation
• Selected applicants will be required to complete an online onboarding process
• Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP)
• Participation in the Coronavirus Disease 2019 (COVID-19) vaccination program is a requirement for all Veterans Health Administration Health Care Personnel (HCP) - See "Additional Information" below for details.

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 10/03/2022.Time-In-Grade Requirement: Applicants who are current Federal employees and have held a GS grade any time in the past 52 weeks must also meet time-in-grade requirements by the closing date of this announcement. For a GS-9 position you must have served 52 weeks at the GS-7. The grade may have been in any occupation, but must have been held in the Federal service. An SF-50 that shows your time-in-grade eligibility must be submitted with your application materials. If the most recent SF-50 has an effective date within the past year, it may not clearly demonstrate you possess one-year time-in-grade, as required by the announcement. In this instance, you must provide an additional SF-50 that clearly demonstrates one-year time-in-grade. Note: Time-In-Grade requirements also apply to former Federal employees applying for reinstatement as well as current employees applying for Veterans Employment Opportunities Act of 1998 (VEOA) appointment.

You may qualify based on your experience and/or education as described below:

• Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-7 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: Experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. To be creditable, specialized experience must have been equivalent to at least the next lower grade level in the normal line of progression for the occupation in the organization. Applicants who have the 1 year of appropriate specialized experience are not required by this standard to have general experience, education above the high school level, or any additional specialized experience to meet the minimum qualification requirements.

OR,

• Education: Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have master's or equivalent graduate degree or 2 full years of progressively higher level graduate education leading to such a degree or LL.B. or J.D., if related.

OR,

• Combination: Applicants may also combine education and experience to qualify at this level. You must have an combination of specialized experience and education to meet total qualification requirements for the grade levels, and may be computed by first determining the applicant's total qualifying experience as a percentage of the experience required for the grade level; then determining the applicant's education as a percentage of the education required for the grade level; and then adding the two percentages. The total percentages must equal at least 100 percent to qualify an applicant for that grade level. Only graduate education in excess of the amount required for the next lower grade level may be used to qualify applicants for positions at grades GS-9 and GS-11. (When crediting education that requires specific course work, prorate the number of hours of related courses required as a proportion of the total education to be used.).

NOTE: For example, an applicant has 6 months of specialized experience equivalent to GS-7 and 1 year of graduate level education. The applicant meets 50 percent of the required experience but none of the required education, since he or she does not have any graduate study beyond that which is required for GS-7. Therefore, the applicant meets only 50 percent of the total requirement and is not qualified for the position. (The applicant's first year of graduate study is not qualifying for GS-9.)You will be rated on the following Competencies for this position:

• Administration and Management
• Communications
• Communications and Media
• Research
• Risk Management

Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religions; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.

Note: A full year of work is considered to be 35-40 hours of work per week. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment.

Physical Requirements: The work requires long periods of time working and keyboarding at a computer workstation. It may involve some walking, standing, bending or carrying of light items. The work is performed in an office or similar setting requiring normal safety precautions against everyday risks or discomforts.

For more information on these qualification standards, please visit the United States Office of Personnel Management's website at https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/ .

Education

A transcript must be submitted with your application if you are basing all or part of your qualifications on education.

Note: Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. You can verify your education here: http://ope.ed.gov/accreditation/ . If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education. For further information, visit: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html .

Additional information

Receiving Service Credit or Earning Annual (Vacation) Leave: Federal Employees earn annual leave at a rate (4, 6 or 8 hours per pay period) which is based on the number of years they have served as a Federal employee. Selected applicants may qualify for credit toward annual leave accrual, based on prior work experience or military service experience. This credited service can be used in determining the rate at which they earn annual leave. Such credit must be requested and approved prior to the appointment date and is not guaranteed.

Special Employment Consideration: VA encourages persons with disabilities to apply, including those eligible for hiring under 5 CFR 213.3102(u), Schedule A, Appointment of persons with disabilities [i.e., intellectual disabilities, severe physical disabilities, or psychiatric disabilities], and/or Disabled veterans with a compensable service-connected disability of 30% or more. Contact the Agency Contact for information on how to apply under this appointment authority via the Selective Placement Coordinator.

The Interagency Career Transition Assistance Plan (ICTAP) and Career Transition Assistance Plan (CTAP) provide eligible displaced Federal/VA competitive service employees with selection priority over other candidates for competitive service vacancies. To be qualified you must submit appropriate documentation (a copy of the agency notice, your most recent performance rating, and your most recent SF-50 noting current position, grade level, and duty location) and be found well-qualified for this vacancy. To be well-qualified : applicants must possess experience that exceeds the minimum qualifications of the position including all selective factors, and who are proficient in most of the required competencies of the job. Information about ICTAP and CTAP eligibility is on OPM's Career Transition Resources website at http://www.opm.gov/policy-data-oversight/workforce-restructuring/employee-guide-to-career-transition/ .This job opportunity announcement may be used to fill additional vacancies.

To ensure compliance with an applicable preliminary nationwide injunction, which may be supplemented, modified, or vacated, depending on the course of ongoing litigation, the Federal Government will take no action to implement or enforce the COVID-19 vaccination requirement pursuant to Executive Order 14043 on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees. Therefore, to the extent a VA job announcement includes language requiring applicants to be fully vaccinated against COVID-19 pursuant to Executive Order 14043, that requirement does not currently apply to this Job Announcement. VA may request information regarding your vaccination status, if selected, for the purposes of implementing other workplace safety protocols, such as masking, physical distancing, testing, travel, and quarantine.

If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application .