Job Specifications
Montgomery county, MD
$120,000 - $160,000 PA
13 hours ago
Full Time
Senior Level
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Lead Program Specialist (Protocol)
The ideal candidate has experience reviewing clinical research protocols and ClinicalTrials.gov documentation; providing guidance on regulatory and IRB requirements; monitoring compliance with submission requirements; working with investigators and research staff to resolve protocol-related issues; and mentoring and training staff on clinical research processes, regulatory requirements, and best practices.
- Identifying, assigning, distributing and balancing workload and tasks among employees in accordance with established workflow, skill level and/or occupational specialization.
- Ensuring that each employee has an integral role in supporting protocol actions that are approved by the IRB and submitted to the PSS for final review and processing by staff.
- Developing and implementing program strategies that support protocol processing, information management, and administrative services for the NIH Intramural Research Program (IRP) to ensure effective support of clinical research activities.
- Providing oversight of protocol action processing by conducting quality assurance reviews to ensure accuracy, consistency, and compliance with established procedures.
- Serving as a principal liaison for the NIH Intramural Research Program to support implementation of and compliance with ClinicalTrials.gov registration requirements for human subjects’ research protocols.
- Identifying and implementing process improvements by analyzing, streamlining, and automating administrative workflows.
Requirements
In order to qualify for a Lead Program Specialist (Protocol) at the GS-13 grade level, you must have 1 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 and evaluating clinical research protocols, amendments, renewals, and related documentation to identify deficiencies and ensure compliance with applicable Federal regulations, policies, and Institutional Review Board (IRB) requirements; 2.) providing technical guidance to investigators, protocol coordinators, and research staff regarding protocol development, submission requirements, regulatory compliance, and IRB processes, including requirements established by Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), and Office of Human Research Protection (OHRP); 3.) monitoring research protocol activities to identify compliance concerns, resolve procedural or documentation issues, and support continued adherence to regulatory and institutional requirements; 4.) analyzing and maintaining protocol related information to support the planning, tracking, and evaluation of research activities and associated program resources; and 5.) serving as a technical resource to investigators, protocol coordinators, and other staff by clarifying protocol requirements, addressing submission or compliance issues, and facilitating the resolution of protocol-related concerns. 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. 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/13051424