Clinical Trials Program Specialist

National Institutes of Health • Montgomery County, MD

6d • Remote

About The Position

The Clinical Trials Program Specialist oversees policies and procedures for NIDDK-funded clinical studies and supports clinical research planning and management across all NIDDK divisions. The position develops and maintains standard operating procedures and oversight tools, applies federal regulations and NIH policies, supports monitoring of study recruitment and performance, contributes to clinical study budgeting, and coordinates data and biospecimen sharing for multicenter studies.

The position requires a bachelor’s degree or graduate/higher-level degree with major study in an academic field related to medicine, health sciences, or allied sciences. Applicants must also have at least one year of qualifying experience equivalent to the GS-12 level, including experience overseeing large, multi-site clinical trials; applying regulations and policies governing clinical research and human-subject protections; developing clinical research policies, procedures, tools, or funding requirements; coordinating research activities among stakeholders; and conducting quality assurance and compliance activities.

The position is designated as non-emergency/teleworker. In the event of a closure, the employee must be available to telework or request leave. Work-schedule flexibilities may be available at the supervisor’s discretion. Appointment may include a one- or two-year trial or probationary period. A Confidential Financial Disclosure Report (OGE Form 450) is required annually.

Requirements

• U.S. citizenship or proof of U.S. National status by the closing date.
• Successfully completed a full four-year course of study at an accredited college or university leading to a bachelor’s degree or graduate/higher-level degree, with major study in medicine, health sciences, or allied sciences appropriate to the work.
• At least one year of qualifying experience equivalent to at least GS-12 in Federal service, obtained in the private or public sector.
• Experience applying federal regulations, policies, guidance, and reporting requirements governing clinical research and human-subject protections.
• Experience developing clinical research policies, procedures, standard operating procedures, tools, or funding requirements.
• Experience overseeing large, multi-site clinical trials and coordinating clinical research among multiple stakeholders.
• Experience conducting quality assurance and compliance activities for clinical research.
• Meet all qualification requirements within 30 calendar days of the announcement closing date, including time-in-grade requirements.
• Males born after December 31, 1959 must be registered with the Selective Service.
• Successful completion of a background investigation, qualification verification, onboarding forms, and other job-related requirements.
• Ability to perform the essential duties of the position, with or without reasonable accommodation.
• Submit a Confidential Financial Disclosure Report (OGE Form 450); financial disclosure is required annually.

Nice To Haves

• A newly appointed or reappointed individual may receive a recruitment incentive, subject to organizational need, case justification, and budget limitations.
• Work-schedule flexibilities may be available at the supervisor’s discretion.

Responsibilities

• 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 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.
• Oversee the management of large, multi-site clinical trials.
• Coordinate clinical research activities among multiple stakeholders and provide technical consultation.
• Conduct quality assurance and compliance activities for clinical research.

Benefits

• Potential recruitment incentive for a newly appointed or reappointed individual, determined case by case and subject to organizational need, justification, and budget limitations.
• Potential work-schedule flexibilities at the supervisor’s discretion.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior