This position is located within the Clinical Trials Unit of the Office of the Clinical Director (OCD), The National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH).

Duties

Collaborate with investigators on protocol navigation, participate in managing a portfolio of clinical trials, and provide regulatory support for Investigators in the Clinical Trials Unit. Provide documents and information as required to meet sponsor submission and ongoing reporting requirements to the Food and Drug Administration (FDA) (e.g., Investigational New Drug [IND] and Investigational Device Exemption [IDE] applications). Coordinate submission of protocols for scientific review by the Branch scientific review committees, including assignment of reviewers and distribution of protocol document for staff review. Collaborate with nurses, IRB personnel, Investigators, contracts, research sponsors and regulatory personnel regarding regulatory issues and requirements and protocol adherence and interpretation. Collaborate with Investigators to create new protocols, and participates in writing/editing patient consent sections, including formatting and adding administrative language. Ensure that the organizations strategic mission, plan, vision and values are communicated to the team of protocol navigators and integrated into the team’s work. Review relevant documents as well as policies and procedures to ensure all meet regulations governing the ethical conduct of research Serve as mentor and guide several protocol navigators within the CTU to ensure all work assignments of the team are carried out to achieve specific tasks, produce work products and services, and meet program goals of NINDS

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 requires Education.

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: providing regulatory guidance, review, and assistance to clinical investigators and other clinical regulatory staff; reviewing clinical protocols for regulatory compliance and internal consistency; ensuring Investigational New Drug (IND) and Investigational Device Exemption (IDE) products are in compliance with regulations and industry best practices; supporting maintenance of safety trackers and databases; and providing professional and technical assistance to staff and research study teams. 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/12474404

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: Michael Kennedy
• Phone: 301-402-6865
• Email: [email protected]