The NIH Clinical Center is seeking a Protocol Monitoring Specialist to serve as an expert in providing research quality assurance and compliance oversight to investigators and teams within the Intramural Research Program (IRP). The ideal candidates will have experience as relates to research quality assurance, clinical research, and federal regulations that govern human subjects and investigational drug and devices research (45 CFR 46 and 21 CFR 312 and 21 CFR 812).

Duties

Reviewing human subject research protocols and evaluates them to identify issues that must be monitored to ensure regulatory compliance with process and documentation requirements and with pertinent laws and regulations. Conducting risk assessments of various research protocols in the IRP. Creating a monitoring and auditing process to address areas identified by the risk assessments related to research compliance areas for the organization. Developing and implements systems for tracking and trending clinical research quality assurance findings. Developing and conducting focused education and training based on findings from risk assessments and audits, enforcement activities, and new policies and regulations. Assisting with the development of standard operating procedures (SOP)'s for monitoring and evaluating regulatory compliance for clinical research and quality assurance activities. Identifying the need for and designs customized audit and evaluation surveys to ensure that protocols meet regulatory requirements, policies and standards and that research funds are being used as identified in the protocol.

Requirements

• 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.
• This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts.
• At the supervisor's discretion, this position may offer work schedule flexibilities: Alternative work schedule and Telework.
• This position is designated as an "non-emergency/teleworker" position. See definition of this designation in the Additional Information Section of this announcement.
• If selected, you must pass a pre-employment medical examination, provide evidence of immunization, and be free from communicable diseases.

Qualifications

Education Qualification Requirement for GS-12 and GS-13: In order to qualify for a Protocol Monitoring Specialist-GS-601, 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 at the time the degree was obtained). Additional Qualification Requirement for GS-12: In addition, in order to qualify for an Protocol Monitoring Specialist-GS-601, at the GS-12 level, you must have at least one year of qualifying specialized experience equivalent to at least the GS-11 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks:interpreting and applying knowledge of various regulations, policies and procedures governing human subject research and investigational drug and devices research; applying a wide range of qualitative and/or quantitative methods for the assessment and compliance of human subject protocols and the improvement of complex management and medical processes and systems; developing and implementing systems for tracking and trending clinical research quality assurance findings; preparing a variety of materials including briefings, project papers, correspondence and presentations; and preparing reports of monitoring and/or audit findings and recommendations. Additional Qualification Requirement for GS-13: In addition, in order to qualify for an Protocol Monitoring Specialist-GS-601, at the GS-13 level, you must have at least one year of qualifying specialized experience equivalent to at least the GS-12 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: conducting research quality assurance review of clinical research that govern human subjects and investigational drug and devices research; formulating, planning and executing specialized projects to ensure quality assurance of human research protocols; designing customized monitoring plans and/or audits of protocols meet regulatory requirements and policies and standards; developing and conducting education and training based on findings from audits and new policies and regulations; and developing SOPs for monitoring and evaluating regulatory compliance for clinical research and quality assurance activities. 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. 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. 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/12601521

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.

Contacts

• Address National Institutes of Health 6701 Rockledge Drive Bethesda, MD 20892 US
• Name: NIH HR Service Desk Branch E
• Email: [email protected]