Summary

Join the National Institutes of Health as a Clinical Trials Program Coordinator and help ensure the quality, safety, and integrity of clinical research programs. We are seeking an experienced professional with expertise in clinical trial design and methodology, quality assurance and control, data and safety monitoring, and federal policies and guidance governing research involving human subjects.

Duties

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• Develop and implement guidelines, standards, project management plans, and study-monitoring plans to ensure the quality and regulatory compliance of NIMH-sponsored clinical trials.
• Plan, coordinate, and conduct routine and for-cause, risk-based monitoring and audits of clinical research studies, coordinating centers, and clinical sites.
• Review clinical protocols, informed-consent documents, study forms, safety reports, and audit findings to ensure compliance with federal regulations, NIH requirements, and Good Clinical Practice.
• Advise staff, principal investigators, and study personnel on regulatory, clinical, and administrative matters; develop and communicate corrective action plans to resolve compliance issues.
• Develop and refine systems and informatics tools to monitor clinical-trial progress, risk, quality assurance, data integrity, and participant safety.

Requirements

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Conditions of employment

• 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 a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
• Applicants must meet all qualifications requirements within thirty (30) calendar days of the closing date of this announcement, including time in grade.
• Males born after December 31, 1959 must be registered with the Selective Service.
• Must be able to perform the essential duties of the position, with or without reasonable accommodation.
• 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.
• Position requires Education.

Qualifications

To qualify for a Clinical Trials Program Coordinator 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).

In addition you must demonstrate in your resume at least one (1) 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: managing quality assurance and control for clinical research programs; following guidelines and standards for the conduct of clinical trials; monitoring clinical research projects and documentation; reviewing clinical protocols, consent documents, and study forms; and coordinating clinical trials with other scientists, staff, and organizations.

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:

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.

Additional 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 must pass a pre-employment medical examination.
• 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 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.
• 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).

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Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution.

Benefits

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