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

Serving as a team lead for internal safety oversight staff as well as providing oversight and serving as the COR representative for the safety oversight section of the support contract. Serving as a team lead and technical expert in providing regulatory guidance, safety oversight, operational support, and inspections to ensure IND and IDE products are developed by the CCR in compliance with regulations and industry best practices. Participating in clinical trial protocol development and review. Providing comments regarding protocols to comply with OSRO Policies and Procedures, NIH Policies, and ICH Good Clinical Practice guidelines. Evaluating essential regulatory compliance reports for validity and consistency. Establishing standards for clinical site monitoring, essential regulatory document reviews and protocol activity tracking, including implementing risk-based monitoring. Supporting maintenance of safety trackers and databases. Collaborating with Medical Monitors in activities of review, assessment, summarization and reporting of serious adverse event information. Providing regulatory guidance, review, and assistance to clinical investigators and other clinical regulatory staff to ensure documentation and activities conforms to applicable regulations and guidelines. Preparing reports and maintaining records of work accomplishments and administrative information, as required, and coordinating the preparation and communication of work related information to the supervisor.

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.)
• Position requires Education (Please submit transcripts).
• 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.

Qualifications

Education Qualification Requirement: In order to qualify for a Lead Regulatory Operations Specialist-GS-0601-14, position you must have successfully completed a full 4 year course of study in an accredited college or university leading to 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). Additional Qualification Requirement: In addition, in order to qualify for a Lead Regulatory Operations Specialist, GS-0601-14, position you must have at least one (1) year of qualifying specialized experience equivalent to at least the GS-13 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 requirements for clinical trials for Investigational New Drug and Investigational Device Exemption applications; providing guidance on regulations, policies, and procedures governing clinical trials operations and regulatory applications; preparing reports on clinical trials operations and regulatory issues; providing guidance or assistance on clinical trial protocols; 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. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12574331

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]