Clinical Regulatory and Operations Specialist

About this role

To qualify for the Clinical Regulatory and Operations Specialist GS-601, you must meet the following qualification requirements: Education Requirement: You must possess a Bachelor's or graduate/higher level degree: 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. AND Additional Qualifications: You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-13 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: coordinating clinical research operations in response to emerging and re-emerging infectious diseases; supporting the development, technical management, and evaluation of clinical research programs; providing guidance on matters relating to Investigational New Drug (IND) and Investigational Device Exemption (IDE) development, oversight and evaluations; overseeing clinical studies to ensure procedures and policies are within safety protocols.

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.