If you have experience managing clinical trials and providing regulatory support AND you want to play a significant role in a dynamic organization, then consider joining the Center for Cancer Research (CCR), Office of the Clinical Director (OCD) at the National Cancer Institute (NCI)! For more information please visit: https://ccr.cancer.gov/about/office-of-the-clinical-director.

Duties

As a Regulatory Affairs Specialist, your typical work assignments may include: Managing all aspects of the protocol lifecycle including scientific peer review, initial Investigational New Drug Applications (IND) preparation, Institutional Review Board (IRB) submission of protocols, continuing review applications, protocol amendments, and annual reports. Monitoring key ethical and legal issues related to protection of research participants, adherence to policies and federal and state regulations surrounding the collection, storage, dissemination, and use of biospecimens. Serving as a liaison for clinical Investigators and other clinical regulatory staff Providing regulatory guidance, review, and expertise to ensure documentation conforms to applicable regulations and guidelines. Coordinating study site activities pertaining to the compilation and submission of, Institutional Review Board (IRB) applications, including documents for original Investigational New Drug Applications (INDs) for management and multi-disciplinary team review. Preparing and compiling data from ongoing protocols and drafts annual continuing review reports for distribution to appropriate regulatory agencies.

Requirements

• 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 has an education requirement. Please submit transcripts.

Qualifications

Basic Qualifications In order to qualify for a Regulatory Affairs 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 Affairs 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 Affairs 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. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12412946

Education

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.

Contacts

• Address National Institutes of Health 6701 Rockledge Drive Bethesda, MD 20892 US
• Name: Jamie Hammond
• Phone: 301-496-5901
• Email: [email protected]