The Director, Office of Clinical Research, Division of Cardiovascular Sciences (DCVS), National Heart, Lung, and Blood Institute (NHLBI) serves as a Supervisory Clinical Trials Specialist, GS-0601-15. The NHLBI is seeking an exceptional Supervisory Clinical Trials Specialist with expert experience in the management and oversight of ethical, regulatory, and safety aspects of observational studies and clinical trials.

Duties

As a Supervisory Clinical Trials Specialist, you will: Manage the Clinical Research Office, DCVS, NHLBI for extramural projects, and coordinate regulatory activities associated with clinical research with internal and external organizations. Collaborate with NHLBI's Deputy Director for Clinical Research and Strategic Initiatives and NHLBI's Chief Medical Research Officers to create a Community of Practice as it relates to clinical trial stewardship. Serve as the Division's senior advisor to extramural scientific and health care staff, principal investigators, and research staff to support excellent stewardship of NHLBI funded clinical trials and other clinical studies. Direct initiatives of the Office of Clinical Research, including training, development of policies and standard procedures, development of software solutions to facilitate oversight of clinical trials and large observational studies as well as oversight of NHLBI's clinical study monitoring boards. Responsible for central NHLBI Clinical Trials databases. Serve on trans-NHLBI and trans-NIH committees focused on clinical research. Manage activities related to the Operation of Data and Safety Monitoring Boards (DSMB) and Protocol Review Committees. Supervise and manage a team of professional Clinical Trials Specialists and support staff.

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. Official transcripts required.
• 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 Financial Disclosure.

Qualifications

In order to meet the Basic Qualification Requirements for a Supervisory Clinical Trials Specialist, GS-0601-15, you must meet: Education Requirement: You must have a bachelor's or graduate/higher level degree with a major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of this position. All education, unless completed outside of the U.S., must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the education was completed. Additional Qualifications: 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: Managing or overseeing clinical research trials and operational activities ensuring good clinical research practices; promoting the safety and well-being of individuals participating in clinical research; coordinating regulatory activities associated with clinical research; applying experimental theories and new developments to the solution of complex health care problems; implementing clinical trial methodologies, clinical trial and medical record keeping, and quality assurance issues; defining problems, analyzing alternatives, and recommending solutions to complex problems affecting the conduct of clinical research; and providing advice, guidance, and coordination for a variety of issues related to planning and conducting clinical research. 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/12495866

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: David Wittenberg
• Phone: 301-451-1828
• Email: [email protected]