Clinical Trials Program Specialist

Summary

We are seeking a qualified individual to serve as a Clinical Trials Program Specialist, overseeing policies and procedures for NIDDK funded clinical studies. This role supports clinical research planning and management across all NIDDK divisions.

Duties

• Develop and maintain SOPs and oversight tools in alignment with NIH Clinical Trial Task Force recommendations.
• Interpret and apply federal regulations and NIH policies to ensure NIDDK funded clinical studies comply with NIH, NIDDK, and HHS requirements.
• Develop best practices and tools to monitor clinical study recruitment, retention, and performance, and assist Program Directors in resolving study-related challenges.
• Develop clinical study budget principles and projections to support effective financial planning and resource management.
• Monitor clinical study enrollment, compliance, and reporting, including dashboards, data tracking, and annual compliance reviews.
• Coordinate data and biospecimen sharing for multicenter clinical studies with the NIDDK Central Data Repository and Biorepository.

Qualifications

To qualify for a Clinical Trials Program Specialist at the GS-0601-13 level you must: Have successfully completed a full 4 year course of study in an accredited college or university leading to 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 at the time the degree was obtained). AND 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: Overseeing the management of large, multi-site clinical trials; Applying Federal regulations, policies, guidance, and reporting requirements governing clinical research and human subjects protections; Developing clinical research policies, procedures, standard operating procedures, tools, or funding requirements; Coordinating clinical research activities among multiple stakeholders, to include providing technical consultation; AND Conducting quality assurance and compliance activities for clinical research. 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/13094350

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. How You Will Be Evaluated

You will be evaluated based on how well you meet the qualifications listed in this vacancy announcement. Your qualifications will be evaluated based on your application materials (e.g., resume, supporting documents), your responses on the application questionnaire, and your responses to all assessments required for this position. You will be assessed on the following competencies: Attention to Detail Customer Service Flexibility Integrity/Honesty Interpersonal Skills Reading Comprehension Self-Management Stress Tolerance Teamwork Overstating your qualifications and/or experience in your application materials or application questionnaire may result in your removal from consideration. Cheating on an assessment may also result in your removal from consideration. The position(s) advertised in this announcement are covered by the agency's Reemployment Priority List (RPL). RPL candidates will be rated, placed into one of the quality categories below, and referred to the hiring office, once veterans' preference is applied. Qualified Well Qualified Best Qualified Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS. To be considered well qualified for the purposes of the Career Transition Assistance Program (CTAP) and the Interagency Career Transition Assistance Program (ICTAP), you must be able to satisfactorily perform the duties of the position upon entry and substantively exceed the basic qualifications by scoring at least 80 points on the assessment(s) and meet all eligibility, physical, medical, suitability, and all other requirements. Other Information

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. 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/fd. PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration. Visit Help Applying for helpful information on the application process. Military Spouses selected from this announcement will remain in their current duty location (i.e., the official duty station of the military service member. 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. At the supervisor's discretion, this position may offer work schedule flexibilities. Based on your appointment, a one or two-year trial/probationary period may be required. A decision regarding your continued employment with NIH will be made as you near the end of this period. If you believe you have a disability (i.e., physical or mental), covered by the Rehabilitation Act of 1973 as amended that would interfere with completing the USA Hire Competency Based Assessments, you will be granted the opportunity to request a RA in your online application. Requests for RA for the USA Hire Competency Based Assessments and appropriate supporting documentation for RA must be received prior to starting the USA Hire Competency Based Assessments. Decisions on requests for RA are made on a case-by-case basis. If you meet the minimum qualifications of the position, after notification of the adjudication of your request, you will receive an email invitation to complete the USA Hire Competency Based Assessments, based on your adjudication decision. You must complete all assessments within 48 hours of receiving the URL to access the USA Hire Competency Based Assessments if you received the link after the close of the announcement. To determine if you need a RA, please review the Procedures for Requesting a Reasonable Accommodation for Online Assessments here: Reasonable Accommodation Information. Veterans' Preference only applies to Schedule A (disability appointment), HHS Reemployment Priority List (RPL) Eligibles, HHS Priority Reemployment List (PRL) Eligibles, and Veterans Recruitment Appointments (if applicable).