About this role
Job SummaryJoin 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.
QualificationsTo 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: https://apply.usastaffing.gov/ViewQuestionnaire/13032895
Major DutiesDevelop 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.