Regulatory and Clinical Operations Specialist

Basic Qualifications In order to qualify for a Regulatory Operations Specialist, GS-0601, position you must have successfully completed a bachelor’s degree or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. (This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education (https://ope.ed.gov/accreditation) at the time the degree was obtained). Additional Qualifications GS-12: In addition, to qualify for a Regulatory Operations Specialist position at the GS-12 level, you must demonstrate at least one year of specialized experience equivalent to at least the GS-11 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: monitoring clinical trials to ensure applicable regulations, guidelines, and clinical practices are followed; serving as liaison and providing regulatory guidance for clinical investigators and other clinical regulatory staff; reviewing and submitting Investigational New Drug Applications (IND) and Investigational Device Exemptions (IDE) to review committees and regulatory bodies; and providing administrative and technical support to investigators involved in clinical trial research efforts. GS-13: In addition, to qualify for a Regulatory Operations Specialist position at the GS-13 level, you must demonstrate at least one year of specialized experience equivalent to at least the GS-12 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: managing a portfolio of clinical trials to include protocol navigation, regulatory support and document preparation; serving as liaison and providing regulatory guidance for clinical investigators and other clinical regulatory staff; coordinating submission of protocols to scientific review panels/committees for consideration; preparing and submitting Investigational New Drug Applications (IND) and Investigational Device Exemptions (IDE) to review committees and regulatory agencies; and providing administrative and technical support to investigators involved in clinical trial research efforts. You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay. Do not copy and paste the duties, specialized experience, or occupational assessment questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position. To determine your qualifications and referral status, we may review your resume and supporting documentation and compare it against your responses to the vacancy questionnaire. Ensure you support your self-ratings with the information you provide in your application. We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as knowing your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin before receiving an offer. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12586422
This position is located in the Office of Sponsor and Regulatory Oversight (OSRO), Office of Clinical Director (OCD), Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH), Department of Health and Human Services (HHS).