The National Program Director, Site Monitoring and Auditing Resource Team (SMART) position is located within the Cooperative Studies Program (CSP), Office of Research and Development (ORD) at Department of Veterans Affairs (VA). This position will be filled by a Psychologist, Pharmacist or Nurse.
1 vacancy for the National Program Director position will be filled at Albuquerque, New Mexico or Remote location within the United States. Residence in Albuquerque, New Mexico preferred.
Summary
The National Program Director, Site Monitoring and Auditing Resource Team (SMART) position is located within the Cooperative Studies Program (CSP), Office of Research and Development (ORD) at Department of Veterans Affairs (VA). This position will be filled by a Psychologist, Pharmacist or Nurse.
1 vacancy for the National Program Director position will be filled at Albuquerque, New Mexico or Remote location within the United States. Residence in Albuquerque, New Mexico preferred.
The SMART Director must demonstrate an execution of leadership that is categorized as a significant and incessant responsibility and accountability for the safety of patients volunteering to participate in multicentered clinical trials sponsored by the Department of Veterans Affairs (VA), Office of Research and Development {ORD} Cooperative Studies Program (CSP) or cosponsored with other Federal agencies (e.g. NIH, DOD, PHS, etc.) or industry; this leadership significantly influences the VA ORD mission and health care via Good Clinical Practice (GCP) auditing/ monitoring of multicenter clinical trials in the VA ORD CSP.
The Cooperative Studies Program (CSP) is a Program within VHA's Office of Research and Development (ORD). CSP's mission is to advance the health and care of veterans and the nation through cooperative research studies that produce innovative and effective solutions to national healthcare problems. Specializing In very large-scale clinical research studies within the VA, across the United States, and internationally, CSP has conducted many landmark studies and continues to advance the practice of medicine, Including genomic medicine. The CSP currently maintains a diverse portfolio of clinical research studies that seeks to provide definitive answers to important clinical questions on a range of diseases that affect Veterans and the nation.
The Site Monitoring, Auditng and Resources Team (SMART) is the only entity of its type in medical research programs in the federal government and is managed by a Director with highly and specially trained, and experienced GCP monitors and auditors. The mission of SMART is to promote, monitor and audit compliance with GCP and regulatory requirements (VA and FDA) governing clinical trials in the CSP throughout the U.S. Monitoring and auditing of clinical trials assures the rights and safety of patients participating are protected; reported clinical trial data are accurate, complete, and verifiable from source documents; and the conduct of the clinical trial is compliant with the protocol, GCP and applicable FDA and VA regulatory requirements.
The SMART Director manages and directs:
The national GCP Clinical Quality Control and Assurance Program for CSP,
Provides support for Program and policy development,
Directs and supervises Clinical Quality Control and Assurance site inspections (Site and Sponsor),
Trends site visit findings for CSP quality improvement,
Directs the GCP training program for VA researchers and CSP site monitors/auditors,
Oversees the development of tools, worksheets, and GCP guidance for each new CSP clinical trial.
Work Schedule: Monday to Friday, 8:00 AM to 4:30 PM MST/PST Telework: Available Virtual/Remote: Available at supervisor's discretion Financial Disclosure Report: Not required
Selective Service Registration is required for males born after 12/31/1959
You may be required to serve a probationary period
Subject to a background/security investigation
Must be proficient in written and spoken English
Selected applicants will be required to complete an online onboarding process
Must pass pre-employment physical examination
Qualifications
Basic Requirements:
United States Citizenship: Non-citizens may only be appointed when it is not possible to recruit qualified citizens in accordance with VA Policy.
Education: Graduate of a school of professional nursing approved by the appropriate State-accrediting agency and accredited by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on Collegiate Nursing Education (CCNE). In cases of graduates of foreign schools of professional nursing, possession of current, full, active and unrestricted registration will meet the requirement of graduation from an approved school of professional nursing. OR The completion of coursework equivalent to a nursing degree in a MSN Bridge Program that qualifies for professional nursing registration constitutes the completion of an approved course of study of professional nursing. Students should submit the certificate of professional nursing to sit for the NCLEX to the VA along with a copy of the MSN transcript. (Reference VA Handbook 5005, Appendix G6) OR In cases of graduates of foreign schools of professional nursing, possession of a current, full, active and unrestricted registration will meet the requirement for graduation from an approved school of professional nursing.
License: Current, full, active, and unrestricted registration as a graduate professional nurse in a State, Territory or Commonwealth (i.e., Puerto Rico) of the United States, or the District of Columbia.
Nurse IV Grade Determinations:
The following criteria must be met in determining the grade assignment of candidates, and if appropriate, the level within a grade:
Nurse IV - Master's degree in nursing or related field with BSN and approximately 4-5 years of nursing practice/experience; OR a Doctoral degree in nursing or related field and appropriate basic or advanced certification desired, and approximately 3-4 years of nursing practice/experience.
Reference: VA Regulations, specifically VA Handbook 5005, Part II, Appendix G-6 Nurse Qualification Standard. This can be found in the local Human Resources Office.
Preferred Experience:
At Least five years of experience in the monitoring of compliance with Good Clinical Practices (GCP) for multicentered clinical trials.
At least 5 years of experience in the auditing of compliance with Good Clinical Practices (GCP) for multicentered clinical trials.
Have accreditation or certification as a Certified Clinical Research Associate (CCRA) through the Association of Clinical Research Professionals or Society of Clinical Research Associates (SOCRA).
Physical Requirements: Work is generally sedentary, but does require at least occasional visits to facilities
Education
IMPORTANT: 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
Annual leave shall accrue for full-time Nurses, and Nurse Anesthetists at the rate of 8 hours for each full biweekly pay period.
This job opportunity announcement may be used to fill additional vacancies.
It is the policy of the VA to not deny employment to those that have faced financial hardships or periods of unemployment.
This position is in the Excepted Service and does not confer competitive status.
VA encourages persons with disabilities to apply. The health-related positions in VA are covered by Title 38, and are not covered by the Schedule A excepted appointment authority.
Veterans and Transitioning Service Members: Please visit the VA for Vets site for career-search tools for Veterans seeking employment at VA, career development services for our existing Veterans, and coaching and reintegration support for military service members.
If you are unable to apply online view the following link for information regarding an Alternate Application.
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
How you will be evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE MAY NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Your application, résumé, C.V., and/or supporting documentation will be verified. Please follow all instructions carefully. Errors or omissions may affect consideration for employment.
NOTE: Candidate's education and length of nursing practice (experience) will be considered by a Nurse Professional Standards Board in determining the grade and salary of the applicant selected. The recommended salary may be at any point in the range listed for this vacancy.
Experience as an RN will be evaluated to determine if the experience is of an acceptable level of quality with regard to the following four dimensions of nursing: Practice, Professional Development, Collaboration and Scientific Inquiry. Each dimension of practice has criteria that demonstrate essential core competencies for VHA Nursing Personnel.
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.
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
The following documents are accepted, and may be required if applicable to your eligibility and/or qualifications for this position. Please use this checklist to ensure you have included all documents required for your application, such as a copy of your transcript (if using education to qualify), SF-50's (current/former Federal employees), etc.
Cover Letter
DD-214/ Statement of Service
Disability Letter (VA)
License
VA form 10-2850A
Resume
SF-50/ Notification of Personnel Action
Transcript
If you are relying on your education to meet qualification requirements:
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
All applicants are encouraged to apply online. To apply for this position, you must complete the full questionnaire and submit the documentation specified in the Required Documents section below. The complete application package must be submitted by 11:59 PM (ET) on 09/21/2020 to receive consideration. To preview the questionnaire click https://apply.usastaffing.gov/ViewQuestionnaire/10900243.
To begin, click Apply Online to create a USAJOBS account or log in to your existing account. Follow the prompts to select your USA JOBS resume and/or other supporting documents and complete the occupational questionnaire.
Click Submit My Answers to submit your application package.
NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date.
To verify your application is complete, log into your USA JOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the more information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process. To return to an incomplete application, log into your USA JOBS account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USA JOBS account or your application will be incomplete.
NOTE: Participation in the seasonal influenza program is a condition of employment and a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). HCP are individuals who, during the influenza season, work in VHA locations where patients receive care or who come into contact with VA patients as part of their duties. VHA locations include, but are not limited to, VA hospitals and associated clinics, community living centers (CLCs), community-based outpatient clinics (CBOCs), domiciliary units, Vet centers and VA-leased facilities. HCP include all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work at these facilities. HCPs that are unable to receive or otherwise decline a flu shot will be expected to wear a face mask throughout the influenza season.
Raymond G Murphy Department of Veterans Affairs Medical Center
1501 San Pedro Drive, Southeast
Albuquerque, NM 87108
US
Next steps
Once your online application is submitted you will receive a confirmation notification by email. After we receive application packages (including all required documents) and the vacancy announcement closes, we will review applications to ensure qualification and eligibility requirements are met. After the review is complete, a referral certificate(s) is issued and applicants will be notified of their status by email. Referred applicants will be notified as such and may be contacted directly by the hiring office for an interview. All referred applicants receive a final notification once a selection decision has been made.
You may check the status of your application at any time by logging into your USA Jobs account and clicking on Applications. Information regarding your application status can be found in the USAJobs Help Center.
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
The following documents are accepted, and may be required if applicable to your eligibility and/or qualifications for this position. Please use this checklist to ensure you have included all documents required for your application, such as a copy of your transcript (if using education to qualify), SF-50's (current/former Federal employees), etc.
Cover Letter
DD-214/ Statement of Service
Disability Letter (VA)
License
VA form 10-2850A
Resume
SF-50/ Notification of Personnel Action
Transcript
If you are relying on your education to meet qualification requirements:
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
All applicants are encouraged to apply online. To apply for this position, you must complete the full questionnaire and submit the documentation specified in the Required Documents section below. The complete application package must be submitted by 11:59 PM (ET) on 09/21/2020 to receive consideration. To preview the questionnaire click https://apply.usastaffing.gov/ViewQuestionnaire/10900243.
To begin, click Apply Online to create a USAJOBS account or log in to your existing account. Follow the prompts to select your USA JOBS resume and/or other supporting documents and complete the occupational questionnaire.
Click Submit My Answers to submit your application package.
NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date.
To verify your application is complete, log into your USA JOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the more information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process. To return to an incomplete application, log into your USA JOBS account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USA JOBS account or your application will be incomplete.
NOTE: Participation in the seasonal influenza program is a condition of employment and a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). HCP are individuals who, during the influenza season, work in VHA locations where patients receive care or who come into contact with VA patients as part of their duties. VHA locations include, but are not limited to, VA hospitals and associated clinics, community living centers (CLCs), community-based outpatient clinics (CBOCs), domiciliary units, Vet centers and VA-leased facilities. HCP include all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work at these facilities. HCPs that are unable to receive or otherwise decline a flu shot will be expected to wear a face mask throughout the influenza season.
Raymond G Murphy Department of Veterans Affairs Medical Center
1501 San Pedro Drive, Southeast
Albuquerque, NM 87108
US
Next steps
Once your online application is submitted you will receive a confirmation notification by email. After we receive application packages (including all required documents) and the vacancy announcement closes, we will review applications to ensure qualification and eligibility requirements are met. After the review is complete, a referral certificate(s) is issued and applicants will be notified of their status by email. Referred applicants will be notified as such and may be contacted directly by the hiring office for an interview. All referred applicants receive a final notification once a selection decision has been made.
You may check the status of your application at any time by logging into your USA Jobs account and clicking on Applications. Information regarding your application status can be found in the USAJobs Help Center.
Fair and transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
