This position is located in the Food and Drug Administration,
Office of the Commissioner (OC), Oncology Center of Excellence
(OCE) which mission is to achieve patient-centered regulatory
decision-making through innovation and collaboration; and direct
and develop strategies, plans, policies and budgets that focus on
Learn more about this agency
- Responsible for staffing the OCE Project Facilitate program and
call center which assists oncology healthcare providers in
obtaining investigational drugs for patients with cancer.
- Works on projects within the OCE and FDA Oncology as provided
by the Center Director and Supervisory Associate Director for
- Compiles data to prepare special reports related to the work of
the Project Facilitate program and develops background data
pertinent for FDA programs.
- Collaborates with other Center staff and industry officials to
ensure that scientific issues related to the drug's development are
fully addressed in a fair and equitable manner.
- Reviews safety reports and annual reports that are submitted to
the Investigational New Drugs (IND).
25% or less - You may be expected to travel for this
0601 General Health Science
Conditions of Employment
- Citizenship Requirement: You must be a U.S. Citizen to be
considered for this advertisement unless explicitly stated
- FDA participates in e-Verify: All new hires must complete the
I-9 form; this information will be processed through e-Verify to
determine your employment eligibility. If a discrepancy arises, you
must take affirmative steps to resolve the matter.
- Selective Service Registration: All applicants born male, on
(or after) 12/31/1959, must be registered with the Selective
Service System OR have an approved exemption. Visit www.SSS.gov for
- Background Investigation Requirement: All employees must pass a
security investigation. Failing to pass the background check may be
grounds for removal or legal action. If hired, you may be subject
to additional investigations at a later time.
- Time-in-Grade Requirement: If you are applying as a current
Federal employee, you must meet the time-in-grade requirements
described in the Qualifications section, generally, 52-weeks of
comparable experience at the next lowest grade.
- Certification of Accuracy: All information concerning
eligibility and qualification is subject to investigation and
verification. False representation may be grounds for
non-consideration, non-selection, or appropriate legal action.
- You must meet ALL requirements by the closing date of this
announcement to be considered. Only education, experience, and
qualifications attained by this date will be considered. You must
continue to meet all requirements through the hiring process.
- Direct Deposit: You will be required to have all federal salary
payments electronically deposited into a bank account with a
financial institution of your choice.
- Additional selections may be made from this vacancy, within the
same geographical area, by other organizational elements from
within FDA, through shared corporate recruiting activities.
The position of Clinical Analyst falls within the 0601
occupational series. To qualify for this position at grade GS-14,
you must meet Time-in-Grade requirements by 11:59 pm EST on
Time-in-Grade: Any individual who is currently holding, or has
held within the previous 52 weeks, a General Schedule position
under non-temporary appointment in the competitive or excepted
service, must meet time-in-grade requirements (must have served 52
weeks at the next lower grade or equivalent in the Federal
service). Time-in-grade requirements must be met by the closing
date of this announcement.
In addition to meeting Time-in-Grade requirements above, you
must also meet the following Basic Education and Specialized
Basic Education Requirement: Bachelor's or graduate/higher level
degree: major study in an academic field related to the medical
field, health sciences or allied sciences. This degree must be from
an educational program from an accrediting body recognized by the
U.S. Department of Education (external link) at the time the degree
was obtained (MUST SUBMIT TRANSCRIPT/S AT TIME OF APPLICATION).
Have one year of specialized experience equivalent to the GS-13
grade level in the Federal Service which includes experience in
evaluating development plans and study protocols to determine if
the Investigational New Drugs (IND) are safe and effective;
providing clinical and regulatory expertise in evaluating expanded
access requests for individual patients with cancer; planning,
preparing and assisting in organizing symposia, conferences,
scientific meetings, and/or workshops.
In accordance with Office of Personnel Management policy,
federal employees are assumed to have gained experience by
performing duties and responsibilities appropriate for their
official series and grade level as described in their position
description. Experience that would not normally be part of the
employee's position is creditable, however, when documented by
satisfactory evidence, such as a signed memorandum from the
employee's supervisor or an SF-50 or SF-52 documenting an official
detail or other official assignment. The documentation must
indicate whether the duties were performed full time or, if part
time, the percentage of times the other duties were performed. It
is expected that this documentation is included in the employee's
official personnel record. In order to receive credit for
experience in your resume that is not within the official series
and grade level of your official position, you must provide a copy
of the appropriate documentation of such experience as indicated
PHS Commissioned Corps Officers interested in performing the
duties of this position within the Commissioned Corps may apply
online to this announcement. Candidates will be referred to (CC)
personnel and not as candidates for conversion to a permanent
career or career-conditional appointment.
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 USAJOBS
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.
IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE
WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications
are based on breadth/level of experience. In addition to describing
duties performed, applicants must provide the exact dates of each
period of employment (from MM/YY to MM/YY) and the number of hours
worked per week if part time. As qualification determinations
cannot be made when resumes do not include the required
information, failure to provide this information may result in
disqualification. Applicants are encouraged to use the USAJOBS
Resume Builder to develop their federal resume.
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.
You must submit supporting documentation to verify your
eligibility to apply for this vacancy.
For internal applicants an SF-50 will be required. If
Educational requirements are listed, you must submit a Transcript,
even if you occupy the series/grade in question. See the Required
Documents section for full details...
Positions which are scientific or technical in nature often have
very specific educational requirements. You must submit an official
transcript, unofficial transcript, or a list including courses,
grades earned, completion dates, and quarter and semester hours
earned. If you are using education completed in foreign colleges or
universities, see the Foreign Education section below for
Pay careful attention to the Qualifications and Education
sections to identify vacancies where a transcript is required. Even
if you hold a similar position or are a current employee, you are
not exempt from transcript requirements.
Electronic Transcript Caution: If you have obtained your
transcripts electronically, the file might contain security
measures that could prevent our application system from reading the
file. Therefore, you should consider asking the institution to
provide the file in a non-secured electronic format. Alternatively,
you could scan or take a photo of the printed copy of the
transcript. If your uploaded transcript cannot be read by our
system, you may receive consideration and credit for the
information we can access.
See the Application Manager Documentation for tips on submitting
your paper-based documents.
using part or all of their education completed outside of the
U.S. to meet the qualification requirements
- must have their foreign education evaluated by an accredited
organization to ensure that the foreign education is comparable to
education received in accredited educational institutions in the
U.S. We will only accept the completed foreign credential
To be acceptable, the foreign credential evaluation must
include/describe at a minimum, the following information: (1) The
type of education received by the applicant; (2) The level of
education in relation to the U.S. education system, and state that
its comparability recommendations follow the general guidelines of
the International Evaluation Standards Council; (3) The content of
the applicant's educational program earned abroad, and the standard
obtained; (4) The status of the awarding foreign school's
recognition and legitimacy in its home country's education system;
and (5) Any other information of interest such as what the
evaluation service did to obtain this information, the
qualifications of the evaluator, and any indications as to other
problems such as forgery.
Note: Some positions require the completion of specific courses
or a specified number of credit hours. Therefore, the foreign
credential evaluation should provide information similar to that of
an official transcript, to include a list of the courses taken,
quarter and/or semester hours awarded, the cumulative grade point
average (GPA), honors received, if any, date degree awarded.
Applicants can request an evaluation from a member organization
of one of the two national associations of credential evaluation
services listed below:
- National Association of Credential Evaluation Services
- Association of International Credentials Evaluators
Credential evaluations are not free, and applicants are
responsible for the cost of the selected service.
For more information about this requirement, please visit the
U.S. Department of Education website for Foreign Education