OER is seeking potential candidates to fill the role of the Director, Division of Human Subjects and Clinical Trials. The ideal candidate will have direct experience and expertise in areas related to clinical research and human subjects protection issues.
Summary
OER is seeking potential candidates to fill the role of the Director, Division of Human Subjects and Clinical Trials. The ideal candidate will have direct experience and expertise in areas related to clinical research and human subjects protection issues.
As a Supervisory Physician (Research) and Director, Division of Human Subjects and Clinical Trials, some of your duties and responsibilities will include, but not limited to the following:
Manage and direct the work of a staff of professional employees.
Evaluate the effectiveness of program supervised in terms of mission accomplishment, quality and quantity standards, procedural policy, regulatory compliance, and technical competence.
Serve as an expert resource to Institutes and Centers (ICs )with respect to NIH human subjects research policies, practices and guidelines.
Oversee the development of training materials for NIH Staff with clinical trials stewardship responsibilities as well as extramural applicants and awardees.
Represent NIH OER to other NIH components (NLM, OSP) and liaise with other organizations and federal agencies such as OHRP, CDC, FDA, to facilitate concerns, collaborate on mitigating issues and information sharing.
Participate in and attend training to keep abreast of the latest state of the art Good Clinical Practices and Regulatory Affairs in Clinical Trials Operations, Oversight and Compliance monitoring.
U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
Position is subject to a background investigation.
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. Provide transcripts.
Qualifications
You qualify at the GS-15 level, if you meet the following qualification requirements:
Education Requirement
A. Successful completion of the requirements for Doctor of Medicine or Doctor of Osteopathic Medicine, or equivalent, from a school in the United States or Canada. This degree must have been accredited by the Council on Medical Education of the American Medical Association; Association of American Medical Colleges; Liaison Committee on Medical Education; Commission on Osteopathic College Accreditation of the American Osteopathic Association; or an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. For further information, please visit OPM's qualification standard; OR
B. Successful completion of a Doctor of Medicine or equivalent degree from a foreign medical school that provided education and medical knowledge substantially equivalent to accredited schools in the United States that was demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates (ECFMG); OR
C. Successful completion of premedical education in the United States AND graduate education from a foreign medical school that provided education and medical knowledge substantially equivalent to accredited schools in the United States that was demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates (ECFMG).
D. Successful completion of the U.S. Medical Licensing Examination.
Graduate Training Requirement
Subsequent to obtaining a Doctor of Medicine or Doctor of Osteopathic Medicine degree, I have had at least 1 year of supervised experience providing direct service in a clinical setting, i.e., a 1-year internship or the first year of a residency program in a hospital or an institution accredited for such training. Graduate training programs include only those internship, residency, and fellowship programs that are approved by accrediting bodies recognized within the United States or Canada. Descriptions of such programs are described below:
An internship program involves broadly based clinical practice in which physicians acquire experience in treating a variety of medical problems under supervision (e.g., internal medicine, surgery, general practice, obstetrics-gynecology, and pediatrics). Such programs are in hospitals or other institutions accredited for internship training by a recognized body of the Accreditation Council for Graduate Medical Education (ACGME); OR
A residency program involves training in a specialized field of medicine in a hospital or an institution accredited for training in the specialty by a recognized body of the American Medical Association, (AMA) or Accreditation Council for Graduate Medical Education (ACGME); OR
A fellowship program involves advanced training (beyond residency training) in a given medical specialty in either a clinical or research setting in a hospital or an institution accredited in the United States for such training.
Additional Qualification Requirements - You must have five years of graduate training in the specialty of the position to be filled; OR equivalent experience and training.
AND
You must have at least one year of qualifying specialized experience equivalent to at least the GS-14 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: providing leadership in the planning, directing and coordination of biomedical clinical research programs and activities, including administrative, regulatory and scientific matters; managing and evaluating research projects that are broad and complex in scope and require unconventional approaches or complex research techniques; establishing goals and objectives for assigned research area, and coordinating efforts to facilitate the resolution of critical issues involving accomplishment of the research; reviewing research data and progress reports, and implementing corrective actions needed to achieve established research goals and objectives; making recommendations to senior personnel for facilitating new research efforts, clinical studies, clinical trials, or other initiatives required to meet program needs; and planning and arranging national or regional seminars and symposia leading to the more rapid dissemination of scientific data.
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; religious; 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.
This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education.
Additional information
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.
This position is designated as a "non-emergency/teleworker" position and the selected candidate will be considered a "non-emergency/teleworker" employee. In the event of a closure, you must be available to telework or request leave.
A one-year supervisory trial/probationary period may be required upon selection/ placement.
At the supervisor's discretion, this position may offer work schedule flexibilities: [telework, remote work, compressed schedules, flexible schedules].
NIH may repay certain outstanding Federally-insured student loans to facilitate the recruitment and retention of highly qualified people. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
A newly appointed or reappointed employee may receive service credit for prior work experience or active duty uniformed service that otherwise would not be creditable for the purpose of determining his or her annual leave accrual rate. All creditable service must be directly related to the duties of the position being filled and decisions to allow for such credit must be finalized prior to the selectee's entrance on duty. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
Physicians Comparability Allowance of up to $30,000 per annum may be paid based on the selected physician's assignment, qualifications, experience, and duration of a negotiated service agreement.
A newly appointed or reappointed individual may receive a recruitment incentive. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should also apply online to this announcement in order to receive consideration.
We may make additional selections for similar positions within the commuting area(s) of the locations listed through this vacancy announcement.
The National Institutes of Health participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.
The NIH maintains a tobacco free work environment and campus.
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.
Traditional rating and ranking of applications does not apply to this vacancy. You will be evaluated against the basic qualifications. Qualified applicants will be referred for consideration in accordance with the Office of Personnel Management direct hire guidelines. Veterans' Preference does not apply to the direct hire recruitment procedures.
To be considered well qualified for the purposes of the Career Transition Assistance Program (CTAP) and the Interagency Career Transition Assistance Program (ICTAP), you must substantively exceed the basic qualifications and meet all eligibility, physical, medical, suitability, and all other requirements.
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.
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 theUSAJOBS 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 need to 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.
Assessment Questionnaire:
You must submit a completed assessment questionnaire.
All of the above information is necessary to determine your qualifications for the position. Please help us make an informed decision regarding your eligibility by providing complete and thorough information on your experience and qualifications. Not providing all of 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 Career Transition Claims
Visit our websites to claim selection priority through the Career Transition Assistance Program (CTAP) or the Interagency Career Transition Assistance Program (ICTAP):
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.
Please do not submit any other supplementary 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:
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.
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 10/18/2018 to receive consideration.
1. To begin, click Apply to access the online application. You will need to be logged into your USAJOBS account to apply.
2. 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). You will have the opportunity to upload additional documents to include in your application before it is submitted. You must submit your documents through the online application. Unfortunately, we cannot accept emailed or mailed documents. NOTE: that your uploaded documents may take several hours to clear the virus scan process.
3. Read all Eligibility questions and respond accordingly to any Eligibility you wish to claim.NOTE: You will only be considered for those Eligibility questions (Status Applicant, Reinstatement, Schedule A, etc.) you respond in the affirmative to, including veterans' preference, regardless of what documentation you submit. We use these questions to assist in determining your eligibility for appointment, preference, and consideration. We cannot assume you intended to respond differently to a question based on other information in your application package. We cannot accept responsibility for granting you eligibility for something you did not claim other than what you provided us in the questionnaire.
4. Complete the assessment questionnaire. Applicants are asked all questions regardless of their consideration preferences. NOTE: We will only consider you for the grades, series, and specialties that you self-identify as being qualified for. We cannot assume you intended to respond differently to a qualification question based on other information in your application package. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/10324558
5. 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 the following although they are not required at the time of application (these documents may be requested later in the process).
- Cover letter
- Copy of transcripts (if applicable). Official transcripts will be required if selected.
- Copy of current, valid, unrestricted professional license/registration (if applicable).
To check your application status or to update your application, log into your USAJOBS account. Access the USAJOBS help page for guidance on navigating the system.
We cannot assume responsibility or grant extensions for personal issues (e.g., power outage, 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 James Carroll at carrollja@mail.nih.gov.
National Institutes of Health
2115 East Jefferson Street
Rockville, MD 20851
US
Next steps
Once you submit your application package, you will receive an acknowledgement email. Your application will be assessed to determine your qualifications and eligibility for the position. After the assessment is complete, you will be notified of the status via email. In addition, you can track the progress of your application package through your USAJOBS account.
The selecting official, hiring manager, or someone acting on their behalf will review the applications of the referred candidates and determine who to interview. We may contact you for an interview or to provide additional information after a few days or up to several months from the closing date of the announcement. We may contact you through email or phone so please ensure you have provided us with your accurate and current contact information. To remain in consideration for this vacancy announcement, you must respond in a timely manner to our correspondence and requests for documentation or information throughout the selection and hiring process.
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
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 theUSAJOBS 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 need to 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.
Assessment Questionnaire:
You must submit a completed assessment questionnaire.
All of the above information is necessary to determine your qualifications for the position. Please help us make an informed decision regarding your eligibility by providing complete and thorough information on your experience and qualifications. Not providing all of 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 Career Transition Claims
Visit our websites to claim selection priority through the Career Transition Assistance Program (CTAP) or the Interagency Career Transition Assistance Program (ICTAP):
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.
Please do not submit any other supplementary 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:
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.
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 10/18/2018 to receive consideration.
1. To begin, click Apply to access the online application. You will need to be logged into your USAJOBS account to apply.
2. 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). You will have the opportunity to upload additional documents to include in your application before it is submitted. You must submit your documents through the online application. Unfortunately, we cannot accept emailed or mailed documents. NOTE: that your uploaded documents may take several hours to clear the virus scan process.
3. Read all Eligibility questions and respond accordingly to any Eligibility you wish to claim.NOTE: You will only be considered for those Eligibility questions (Status Applicant, Reinstatement, Schedule A, etc.) you respond in the affirmative to, including veterans' preference, regardless of what documentation you submit. We use these questions to assist in determining your eligibility for appointment, preference, and consideration. We cannot assume you intended to respond differently to a question based on other information in your application package. We cannot accept responsibility for granting you eligibility for something you did not claim other than what you provided us in the questionnaire.
4. Complete the assessment questionnaire. Applicants are asked all questions regardless of their consideration preferences. NOTE: We will only consider you for the grades, series, and specialties that you self-identify as being qualified for. We cannot assume you intended to respond differently to a qualification question based on other information in your application package. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/10324558
5. 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 the following although they are not required at the time of application (these documents may be requested later in the process).
- Cover letter
- Copy of transcripts (if applicable). Official transcripts will be required if selected.
- Copy of current, valid, unrestricted professional license/registration (if applicable).
To check your application status or to update your application, log into your USAJOBS account. Access the USAJOBS help page for guidance on navigating the system.
We cannot assume responsibility or grant extensions for personal issues (e.g., power outage, 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 James Carroll at carrollja@mail.nih.gov.
National Institutes of Health
2115 East Jefferson Street
Rockville, MD 20851
US
Next steps
Once you submit your application package, you will receive an acknowledgement email. Your application will be assessed to determine your qualifications and eligibility for the position. After the assessment is complete, you will be notified of the status via email. In addition, you can track the progress of your application package through your USAJOBS account.
The selecting official, hiring manager, or someone acting on their behalf will review the applications of the referred candidates and determine who to interview. We may contact you for an interview or to provide additional information after a few days or up to several months from the closing date of the announcement. We may contact you through email or phone so please ensure you have provided us with your accurate and current contact information. To remain in consideration for this vacancy announcement, you must respond in a timely manner to our correspondence and requests for documentation or information throughout the selection and hiring process.
Fair and transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
