Clinical Trials Specialist

Clinical Trials Specialist

Department: Department of Health and Human Services

Location(s): Montgomery County, Maryland

Salary Range: $102415 - $158322 Per Year

Job Summary: This position resides within the National Heart, Lung, & Blood Institute and will serve as a Clinical Trial Specialist within the extramural divisions.

Major Duties:

• Serve as a scientific resource on research teams collaborating with the Investigator, Protocol Coordinator and other team members to plan, develop and implement research protocols. Assist with the preparation of Manuals of Operation and other study documents such as recruitment brochures, web site content, etc. monitor and review adverse events files and reports and submitting timely and accurate reports on adverse events in accordance with NIH policy; and preparing evaluation reports and developing recommendations. Develop and maintain standard operating procedures for adverse event data collection, processing and reporting systems; collaborate with other staff to evaluate the adequacy of Data and Safety Monitoring Plans and provide recommendations for improvement and compliance. Monitor the regulatory and procedural aspects of clinical site monitoring and performance evaluation and prepare reports and documents for review by the Data and Safety Monitoring Board. Develop background materials for site visits, prepare site visit reports, and identify scientific and administrative issues requiring special attention; review and analyze summary reports of monitoring site visit findings and recommend consistent sanctions to be adhered to if institutions are not in compliance. Develop training materials and conduct training sessions for clinical trials specialists and clinical site coordinators; communicate effectively with staff at all levels involved in the conduct of clinical studies within NIH; conduct literature searched for content background for protocols; assist in preparing articles for publication; and prepare scientific and clinical research material to present at local, regional and national meetings.

Qualifications: Basic Qualifications In order to qualify for a Clinical Trials 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 Clinical Trials 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 service obtained in either the private or public sector, performing the following types of tasks: (1) Preparing comprehensive reports on the progress of clinical trials for review by senior leadership; (2) Reviewing clinical trial protocols for completeness and adherence to standards; (3) Compiling clinical research information for use in presentations; (4) Reviewing consent forms to ensure special considerations are met; and (5) Monitoring research milestones to verify the project is on track. GS-13: In addition, to qualify for a Clinical Trials Specialist position at the GS-13 level you must demonstrate at least one year of specialized 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: (1) Reviewing progress reports to ensure adherence to budgets; (2) Developing and maintaining standard operating procedures for adverse event data collection; (3) Training clinical research staff on policies and procedures impacting clinical trials; (4) Reviewing protocols to ensure compliance with all organizational policies; and (5) Preparing site visit reports and providing recommendations to senior officials. 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 or specialized experience from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position. 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 application questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12928735

How to Apply: Please read the entire announcement and all the instructions before you begin an application. To apply and be considered for this position, you must complete and submit all required questionnaires, assessments, and required documentation as specified in the How to Apply and Required Documents sections. The complete application package must be submitted by 11:59 PM (ET) on the closing date of the announcement to receive consideration. The application process is as follows: Click Apply Online button. Follow the prompts to select your resume and/or other supporting documents to be included with your application package. See the "Required Documents" section for any additional forms and/or supplemental materials required. Read all Eligibility questions and respond accordingly to any Eligibility you wish to claim. You will only be considered for those Eligibility questions (Veteran, Schedule A, etc.) you respond in the affirmative to, regardless of what documentation you submit. We cannot assume you intended to respond differently to a question based on other information in your application package. Complete the application questionnaire. Applicants are asked all questions regardless of their consideration preferences. We will only consider you for the grades, series, locations, specialties, and other considerations that you self-identify as being qualified for or interested in. Preview application questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12928735 After submitting an online application, you will be notified whether or not you are required to take additional online assessments through the USA Hire Competency Based Assessment system. This message will be delivered to you via email notification. The email may be routed to your "Spam" or "Junk" folder. If you are required to complete any USA Hire Assessments, you will be notified after submitting your application. The notification will be provided in your application submission screen and via email. The notification will include your unique assessment access link to the USA Hire system and the completion deadline. Additionally, in USAJOBS you can click "Track this application" to return to your assessment completion notice. Access USA Hire using your unique assessment link. Access is granted through your USAJOBS login credentials. Review all instructions prior to beginning your assessments. You will have the opportunity to request a testing accommodation before beginning the assessments should you have a disability covered under the Rehabilitation Act of 1973 as amended. Set aside at least 3 hours to take the USA Hire assessments; however, most applicants complete the assessments in less time. If you need to stop the assessments and continue later, you can re-use your unique assessment link. Your responses to the USA Hire Assessments will be reused for one year (in most cases) from the date you complete an assessment. If future applications you submit require completion of the same assessments, your responses will be automatically reused. Verify all required documentation is included in your application package, review your responses to the application questionnaire for accuracy, and then submit your application. Visit the USA Hire Applicant Resource Center for practice assessments and assessment preparation resources at https://support-usahire.opm.gov/hc/en-us. In addition to the required documents, we encourage you to submit a cover letter, copy of your transcripts, and any applicable certifications or licenses. Even though this information is not required at the time of application, we may request this information later. We cannot assume responsibility or grant extensions for personal issues (e.g., troubles navigating the application process, loss of internet, not understanding a question) when applying to our announcements. For technical difficulties, contact HR Systems Support between 8:00 AM and 4:30 PM ET Monday through Friday at hrss@nih.gov. For reasonable accommodations not related to USA Hire, please contact Sabina Green at greenso@mail.nih.gov . Requests for reasonable accommodations must be made before the announcement closing date. Visit our site for information on NIH's EEO program, Reasonable accommodation procedures, laws, policy statements, and the operation of the EEO complaint process.

Application Deadline: 2026-05-01