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).

Duties

Provide regulatory guidance, safety oversight, operational support, and inspections to ensure the clinical trials conducted under IND or IDE are developed and conducted by the CCR in compliance with regulations and industry best practices. Serve as a Team Lead for internal safety oversight staff as well as provides oversight and serves as the COR representative for the safety oversight section of the support contract. Ensure that the organization's strategic plan, mission, vision and values are communicated to the team and integrated into the team's strategies, goals, objectives, work plans and work products and services. Manages Serious Adverse Event (SAE) reports: reviews and processes SAE reports and conducts follow-up; notifies regulatory agencies and business partners accordingly; responds to requests from regulatory agencies and collaborators; reviews scientific literature and bibliographic sources; assists with drafting, produces and manages safety reports; evaluates safety profiles; and ensures document filing and archiving. Recommends action based on identified risks. Manages Data and Safety Monitoring Board (DSMB): oversee the assembly, operations and data review of CCR DSMBs. Supports maintenance of safety trackers and databases. Collaborates with Medical Monitors in activities of review, assessment, summarization and reporting of serious adverse event information.

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 the pre-appointment process (i.e., background investigation, verification of qualifications and job requirements, completion of onboarding forms, submission of required documents, etc.)
• Enter job specific requirements-i.e., drug testing, PhD, licensure, filer, etc.
• Males born after December 31, 1959 must be registered with the Selective Service.
• Applicants must meet all qualifications requirements within thirty (30) calendar days of the closing date of this announcement, including time in grade.
• Position requires Education. Please submit transcript(s).
• A one-year supervisory trial/probationary period may be required upon selection/placement.

Qualifications

In order to qualify for a Lead Regulatory and Safety 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 at the time the degree was obtained). In addition, in order to qualify for a Lead Regulatory and Safety Specialist, GS-0601-14, 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 and guidance on regulatory and safety requirements for clinical trials for Investigational New Drug and Investigational Device Exemption applications; providing guidance on regulations, policies, and procedures governing clinical trials regulatory and safety issues; preparing reports on clinical trials regulatory and safety issues; and providing leadership and direction to other staff in accomplishing work activities. 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. 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. 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. review assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12430736

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]