This Health Science Officer position is located in the Chief of Staff Service at the VA Connecticut Healthcare System, West Haven Campus. This position is full-time at 40 hours per week. The purpose of the Deputy Associate Chief of Staff for Research Oversight and Compliance (Deputy ACOS-ROC) is responsible for the planning, coordination, managerial oversight, and maintenance of clinical trials. Provide oversight of the Investigational Drug Service, act as the FDA liaison.

Duties

Major Duties and Responsibilities include but are not limited to: Assists, supports, and oversees investigators and their staff including more than 100 principal investigators and over 800 approved research personnel. Research projects are funded by VA Office of Research & Development (ORD), National Institutes of Health (NIH),Department of Defense (DoD), Industry, Yale University, and non-profit foundations, agencies and corporations. Responsible for the compliance and oversight of clinical trials, research pharmacy, FDA, DEA, SRS, and IACUC policy, regulations, and Standard Operating Procedures for the Research program. Responsible for gathering information, identifying and analyzing issues, and developing recommendations to resolve substantive problems of effectiveness and efficiency of work operations in a program or program support setting. Develops new or modified work methods, organizational structures, records and files, management processes, procedures for administering research compliance, guidelines and procedures, and automating work processes for the conduct of clinical trials and program operations. Initiates and conducts or directs special studies related to challenging ethical or regulatory issues associated with animal subject protection. Initiates and conducts or directs special studies related to challenging ethical or regulatory issues associated with complex investigational drug clinical trials. Monitors research pharmacy and clinical trial staffing qualifications, appointments, and responsibilities including training requirements. Provides written and oral guidance to members of the public, including complainants, and the regulated community regarding issues pertaining to the protection of animal subjects, clinical trial participants, and research safety. Assesses, plans, and evaluates assigned clinical trials to ensure proper coordination between the conduct of research activities and the overall delivery of health care. Participates in the planning and design of projects at the facility, VISN, or national level. When appropriate, directs subordinates in pharmaceutical, outcomes, or biomedical research and development projects. Work Schedule: Full Time, Monday - Friday 08:00 AM - 04:30 PM Compressed/Flexible Work Schedule: Not Authorized Telework/Virtual/Remote Work: VA supports the use of telework as a way to help attract and retain talented individuals in public service, increase worker productivity, and better prepare the agency to operate during emergencies. This position may be authorized for telework. Telework eligibility will be discussed during the interview process. Position Description/PD#:Health Science Officer/PD038010 Relocation or Travel Incentives: Not Authorized Recruitment Incentives: Not Authorized Financial Disclosure Report: Not Required Notifications: This position is not a Bargaining Unit position. Selectee may be required to work at any VA Connecticut Healthcare System campus, as needed. May be required to attend conference at other facilities or other VA sites on occasion. The incumbent may be required to travel to other VA campuses and CBOC's. Selectee may be required to work at any VISN 1 Healthcare System campus, as needed. Current and former Federal employees must submit copies of their most recent SF-50 (Notice of Personnel Action). The SF-50 must identify the position title, series, grade, step, tenure and type of service (Competitive or Excepted). In some cases, more than one SF-50 may be required to show a higher grade previously held. This position is in the Competitive Service. Time-in-Grade Restriction: 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. The grade may have been in any occupation but must have been held in the Federal service.

Requirements

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 04/19/2024. 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-14 position you must have served 52 weeks at the GS-13. 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 s described below: BASIC EDUCATION REQUIREMENT: must have successful completion of a full four (4) year course of study in an accredited college or university leading to a bachelor's or higher degree that included a major field of study or specific course requirements related to the medical field, health sciences or allied sciences appropriate to the work of this position. (The number of semester hours required to constitute a major field of study is the amount specified by the college or university attended. If this number cannot be obtained, twenty-four (24) semester hours will be considered as equivalent to a major field of study). (TRANSCRIPT REQUIRED). In addition to the Basic Education Requirement the applicant must also meet the below specialized experience. You may qualify based on your experience as described below: SPECIALIZED EXPERIENCE GS-14: Must have at least one (1) full year of specialized experience equipped with the knowledge, skill, and ability to successfully perform the duties of the position. This specialized experience must have been equivalent to at least the GS-13 grade level in the Federal service. Examples of specialized experience includes: gathering information, identifying and analyzing issues, and developing recommendations to resolve substantive problems of research compliance in a program or program support setting and the application of qualitative and quantitative analytical techniques that frequently require modification to fit a wider range of variables. Requires knowledge of pertinent laws, regulations, policies, and precedents which affect the use of animals in research and related support resources for the creation and updating of new methods and techniques to streamline care and use processes for the conduct of all of the animal and safety functions and program operations. Monitors and analyzes new legislation, regulations, policies, program initiatives, and requirements, specifically related to clinical drug trials, the use of animal subjects, and research safety. Initiates and conducts or directs special studies related to challenging ethical or regulatory issues associated with animal subject protection. Initiates and conducts or directs special studies related to challenging ethical or regulatory issues associated with complex investigational drug clinical trials. Monitors research pharmacy and clinical trial staffing qualifications, appointments, and responsibilities including training requirements. Provides written and oral guidance to members of the public, including complainants, and the regulated community regarding issues pertaining to the protection of animal subjects, clinical trial participants, and research safety. Assesses, plans, and evaluates assigned clinical trials to ensure proper coordination between the conduct of research activities and the overall delivery of health care. SELECTIVE PLACEMENT FACTOR: Qualified applicants must have research experience including clinical drug trails. You will be rated on the following Competencies for this position Administration and ManagementAnalytical ThinkingCommunicationsComplianceResearch 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 is sedentary. 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.

Contacts

• Address West Haven VA Medical Center 950 Campbell Avenue West Haven, CT 06516 US
• Name: Edward Ford
• Phone: 203 932-5711 X5421
• Email: [email protected]