Duties

• Effectively establish overall priorities for the oversight of clinical trials, monitoring performance and providing guidance.
• Plan, develop, and implement targeted research programs.
• Manage protocol development for clinical studies supported by the Division.
• Ensure protocol compliance with NIH and NHLBI guidelines (e.g., inclusion of women, minorities and children in clinical research; reporting adverse events, etc.).
• Develop protocol budgets as needed.
• Collaborate with the Data Coordinating Center (DCC) to prepare Manuals of Operation and other study documents such as recruitment brochures, website content, etc.
• Collaborate with DCC and FDA to prepare IND, IDE, and PMA applications, assuring that all components of FDA submissions conform to NHLBI policy and FDA regulations.
• Review adverse events, adverse events files, and reports and analyses; ensuring timely and accurate evaluation and reporting of adverse events in accordance with NHLBI policy.
• Use clinical judgement, and in consultation with medical officers, assess possible risks for patient safety, evaluate adequacy of safety data collection and management, and recommend and implement remedial action or propose new scientific study.
• Direct development and maintenance of standard operating procedures for adverse event data collection, processing and reporting systems.
• Perform oversight/managements pertaining to the regulatory and procedural aspects of clinical site monitoring and performance evaluation.
• Evaluate adequacy of Data and Safety Monitoring Plans.
• Develop background materials for site visits for clinical centers and DCCs, and identify scientific and administrative issues requiring special attention.
• Develop training materials, and conduct training sessions for other clinical trials specialists and Clinical site coordinators.
• Serve as an expert resource to NHLBI Divisions and other NIH Institutes with respect to protocol development, implementation, clinical site monitoring, and performance evaluation.
• Prepare periodic reports summarizing progress on clinical trials in the Division, or describing large clinical research programs and their activities.

Requirements

Conditions of Employment

• 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.)
• 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.
• Position requires financial disclosure.

Qualifications

Education:

• 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.

You qualify at the GS-12 level, if you meet the following qualification requirements:

• You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-11 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: preparing comprehensive reports summarizing the progress on clinical trials; conducting clinical trials and targeted research programs; and assisting with protocol development, implementation, clinical site monitoring, and contributing to the presentations of clinical research.

You qualify at the GS-13 level, if you meet the following qualification requirements:

• You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: performing oversight and management pertaining to the regulatory and procedural aspects of clinical research/clinical trials; developing protocol budgets; managing protocol development for clinical studies and monitoring performance; directing the development and maintenance of standard operating procedures for adverse event data collection; and establishing overall priorities for the oversight of clinical trials and performance evaluation.

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.

Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/11292407

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 .

Additional information

If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application .

• Due to COVID-19, we are currently operating in a maximum telework state. If selected, you may be expected to telework. As employees to return to the office, you may be required to report to the location listed on this announcement within 30 calendar days of receiving notice, even if your home/temporary telework site is located outside the local commuting area. At the discretion of the supervisor and NIH policy, you may be eligible for workplace flexibilities, which may include remote work or telework options, and/or flexible work scheduling. These flexibilities may be requested in accordance with NIH Workplace Flexibilities guidance.
• This position is designated as a " non-emergency/teleworker " position and the selected candidate will be considered a " non-emergency/teleworker " employee. In the event of a closure, you must be available to telework or request leave.
• A one-year probationary period may be required upon selection/placement.
• PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration.
• If selected, you will be required to complete a Confidential Financial Disclosure Report, OGE Form 450 to determine if a conflict or an appearance of a conflict exists between your financial interest and your prospective position with the agency. This information is required annually. For information, visit the NIH Ethics website: https://ethics.od.nih.gov/topics/fd.html .
• A newly appointed or reappointed individual may receive a recruitment incentive. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
• A newly appointed or reappointed employee may receive service credit for prior work experience or active duty uniformed service that otherwise would not be creditable for the purpose of determining his or her annual leave accrual rate. All creditable service must be directly related to the duties of the position being filled and decisions to allow for such credit must be finalized prior to the selectee's entrance on duty. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
• Veterans' Preference applies only to Schedule A (disability appointment) and Veterans Recruitment Appointments (if applicable).
• The National Institutes of Health participates in the USCIS Electronic Employment Eligibility Verification Program ( E-Verify ). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.
• The NIH maintains a tobacco free work environment and campus.
• Must be able to perform the essential duties of the position, with or without reasonable accommodation.
• Visit our Applicant FAQs page for helpful information on the application process.
• Visit our Total Compensation page for a detailed look into the benefits, awards, leave, retirement and other incentives employees may receive as part of a rewarding work environment.