Duties

• Collaborate with DAIDS program staff, facilitate the development of regulatory strategies, assemble and submit IND applications and/or TMFs to FDA, and maintains high quality IND applications and/or TMFs.
• Responsible for the oversight of paper and/or electronic TMFs within DAIDS, including implementation prior to study start, upkeep throughout the duration of the study, and proper archival for the Sponsor to meet regulatory requirements.
• Develop, maintain, enhance, and modify DAIDS policies and standard operating procedures on TMF and/or IND matters.
• Analyze and interpret regulations, policies, and procedures, and provides oral and written explanations and advice.
• Coordinate and communicate with other DAIDS, NIAID, and NIH components to ensure consistency and harmonization of TMF and/or IND procedures, strategies, and best practices.
• Serve as liaison with the OPCRO Protection of Participants, Evaluation and Policy Branch during Protocol Registration Office (PRO) team interactions.
• Provide guidance and training on TMF and/or IND regulations and procedures to DAIDS researchers and to domestic and international research organizations involved in DAIDS-sponsored clinical trials.

Requirements

Conditions of Employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
• Applicants must meet all qualification requirements by the closing date of this announcement.
• Males born after December 31, 1959 must be registered with the Selective Service.
• Position requires Education (You are strongly encouraged to submit a copy of your transcripts).

How You Will Be Evaluated

• Benefits

  Review our benefits

• Required Documents

  As a new or existing federal employee, you and your family may have access to a range of benefits. Your benefits depend on the type of position you have - whether you're a permanent, part-time, temporary or an intermittent employee. You may be eligible for the following benefits, however, check with your agency to make sure you're eligible under their policies.

  REQUIRED FOR ALL APPLICANTS
  RESUME:
  Your resume must thoroughly describe how your skills and experiences align to the criteria defined in the "Qualifications" section of this announcement and it must support your responses to the assessment questionnaire. We cannot assume you have performed the necessary experience required for this position regardless of your employment history or academic career.
  To ensure all of the essential information is in your resume, we encourage you to use the USAJOBS online Resume Builder. If you choose to use your own resume, you must ensure it contains all of the required information and you organize it so we can associate the following information for each experience/position:

  • Job title

  • Name of employer

  • Beginning and ending dates of employment (month/day/year format)

  • Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.

  • Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)

  • Series and grade or equivalent (if a federal position)

  If the position has an education requirement or you are qualifying on the basis of education, you must list your education history including the type of degree and your major of study. If the position requires a certain number of credit hours, you are strongly encouraged to list the relevant courses in your resume.
  Do not include a photograph or video of yourself, or any sensitive information (age, date of birth, marital status, protected health information, religious affiliation, social security number, etc.) on your resume or cover letter. We will not access web pages linked on your resume or cover letter to determine your qualifications.
  For resume writing guidance, please visit the following resources: NIH Jobs website, USAJOBS Resource Center, and the USAJOBS Resume Writing Video Tutorial.
  ASSESSMENT QUESTIONNAIRE:
  You must submit a completed assessment questionnaire.
  Unless otherwise stated, we will only use the information above to determine your qualifications. Not providing the required information may result in a determination that you do not meet minimum requirements for the position (e.g., an ineligible rating) or a lower rating.
  REQUIRED DOCUMENTATION FOR PREFERENCE OR ELIGIBILITY CLAIMS
  To claim veterans' preference, career transition selection priority, Schedule A or military spouse eligibility, you must provide the documentation listed below AND respond accordingly to the associated question on the online questionnaire.

  • Veterans' preference (DD-214, VA Disability Letter, etc.): Reference Standard Form 15 (SF-15) for required documentation for 10 point claims. Submission of SF-15 is not required, unless you are claiming derived preference (XP) as described in questions 7, 8, or 9 on the SF-15. In those cases, you must submit a completed SF-15 and the required documentation. For 5 point claims, you must submit your DD-214 (if separated) or any written documentation from the armed forces that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
  • Visit our sites on Career Transition Assistance Program (CTAP)/Interagency Career Transition Assistance Program (ICTAP) for more information and required documentation.
  • Visit our site on the Appointment of Certain Military Spouses for more information and required documentation to verify eligibility.
  • Schedule A Eligibility (Applicants with Disabilities) Applicants who are eligible to be considered under Schedule A must submit appropriate documentation to verify eligibility. Documentation must be obtained from a licensed medical professional (e.g., a physician or other medical professional certified by a state, the District of Columbia, or a U.S. territory to practice medicine); a licensed vocational rehabilitation specialist (i.e., state or private); or any Federal agency, state agency, or agency of the District of Columbia or a U.S. territory that issues or provides disability benefits. The letter must be printed on a medical professional's letterhead and signed. Veterans' preference takes precedence in these appointments.

  The Schedule A and military spouse hiring authorities do not guarantee employment or give an individual preference in the hiring process.
  If you do not provide the required information, we will assume you are not eligible, or you do not wish to be considered for any preference or eligibility.
  Do not submit documentation that is not requested of you. To protect your personal information, we will only send your resume and cover letter to the selecting official or hiring manager.

  If you are relying on your education to meet qualification requirements:

  Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

  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.

• How to Apply

  To apply for this position, please read and follow all instructions in this announcement, complete the online application, and submit the documentation specified in the "Required Documents" section. Your complete application package must be submitted by 11:59 PM Eastern Time (ET) on 03/18/2024 to receive consideration.

  • To begin, click Apply to access the online application. You will need to be logged into your USAJOBS account to apply.

  • Follow the prompts to select your resume and/or other supporting documents to be included with your application package. See the "Required Documents" section for any additional forms and/or supplemental materials required.

  • Read all Eligibility questions and respond accordingly to any Eligibility you wish to claim. You will only be considered for those Eligibility questions (Status Applicant, Reinstatement, Schedule A, etc.) you respond in the affirmative to, regardless of what documentation you submit. We cannot assume you intended to respond differently to a question based on other information in your application package.

  • Complete the assessment questionnaire. Applicants are asked all questions regardless of their consideration preferences. We will only consider you for the grades, series, locations, specialties, and other considerations that you self-identify as being qualified for or interested in. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12249467

  • Verify all required documentation is included in your application package, review your responses to the assessment questionnaire for accuracy, and then submit your application.

  In addition to the required documents, we encourage you to submit a cover letter, copy of your transcripts, and any applicable certifications or licenses. Even though this information is not required at the time of application, we may request this information later.
  We cannot assume responsibility or grant extensions for personal issues (e.g., troubles navigating the application process, loss of internet, not understanding a question) when applying to our announcements. For technical difficulties, contact HR Systems Support between 8:00 AM and 4:30 PM ET Monday through Friday at hrss@nih.gov.
  If you need any other accommodation or assistance with applying, please contact Susie Yi-Miller at yimillersa@mail.nih.gov. Requests for reasonable accommodations must be made before the announcement closing date.
  NIH's EEO and Diversity and Inclusion Policy Statement
  Visit the NIH's Office of Equity, Diversity, and Inclusion site for information on NIH's EEO program, Reasonable accommodation procedures, laws, policy statements, and the operation of the EEO complaint process.

  Agency contact information

  Susie Yi-Miller

  Phone

  301-761-7051

  Email

  yimillersa@mail.nih.gov

  Address

  National Institutes of Health
  6701 Rockledge Drive
  Bethesda, MD 20892
  US

  Next steps

  HHS has a critical preparedness and response mission: HHS protects the American people from health threats, researches emerging diseases, and mobilizes public health programs with domestic and international partners. In support of this mission, HHS offers its employees the opportunity to volunteer to become Federal Civilian Detailees and contribute their unique skills through voluntary temporary assignments to humanitarian emergencies or Departmental priorities countering new and emerging health, safety, and security threats.
  Once you submit your application package, you will receive an acknowledgement email. You will be notified of the status of your applications via email. In addition, you can track the progress of your application package through your USAJOBS account.
  At the discretion of the agency, you may be contacted via phone or email for an interview or to provide additional information up to several months from the closing date of the announcement. Please ensure you have provided accurate contact information. To remain in consideration, you must respond in a timely manner to our correspondence and requests for documentation or information throughout the hiring process.

• Fair and Transparent

  The Federal hiring process is set up to be fair and transparent. Please read the following guidance.

  • Equal Employment Opportunity (EEO) Policy
  • Reasonable accommodation policy
  • Financial suitability
  • Selective Service
  • New employee probationary period
  • Signature and false statements
  • Privacy Act
  • Social security number request

Required Documents

Clarification from the agency

You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.