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Summary This position will be responsible for ensuring the highest level of quality assurance and control for clinical research sponsored and should have specialized knowledge of cancer prevention clinical trials research, good clinical practice regulations, project administration, and project management acquired from extensive experience in the conduct, implementation and oversight of single and multisite clinical trials. Responsibilities Develop and implement guidelines and standards for the conduct of clinical trials in order to ensure data quality and compliance with regulatory requirements for clinical research. Develop and implement project management plans, study monitoring plans and manage and coordinate the risk-based audit/monitoring of clinical research studies including on-site monitoring of clinical trials coordinating centers and/or clinical sites. Provide expert leadership through ongoing interactions with staff, principal investigators, and study staff. Develop and implement well-designed, effective informatics tools and procedures to evaluate clinical trials progress and conducts risk-based evaluations. Participate in meetings and serves as the representative and expert in clinical trials management conduct and oversight. Requirements Conditions of Employment Qualifications In order to qualify for a Clinical Trials Program Coordinator, 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). In addition, in order to qualify for a Clinical Trials Program Coordinator, GS-0601 at the GS-14 level, you must: demonstrate in your resume at least one (1) year of qualifying experience to at least the GS-13 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: managing the development and implementation of guidelines and standards for the conduct of clinical trials; providing guidance on regulations, policies, and procedures governing the conduct of clinical trials; providing ongoing monitoring, review, and evaluation of clinical research projects, documentation, and reports; conducting comprehensive reviews of clinical protocols, consent documents, and study forms; developing and refining systems to oversee the management, efficiency, risk management, and quality assurance of clinical research projects; and coordinating clinical trials activities and issues 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, 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/12535610 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 A one-year probationary period may be required upon selection/placement. PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration We may make additional selections for similar positions within the commuting area(s) of the locations listed through this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s). Clearance of CTAP/ICTAP will be applied for similar positions. A newly appointed or reappointed employee may receive service credit for prior work experience or active duty uniformed service that otherwise would not be creditable for the purpose of determining his or her annual leave accrual rate. All creditable service must be directly related to the duties of the position being filled and decisions to allow for such credit must be finalized prior to the selectee's entrance on duty. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations. NIH may repay certain outstanding Federally insured student loans to facilitate the recruitment and retention of highly qualified people. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations. The National Institutes of Health participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers. The NIH maintains a tobacco free work environment and campus. Must be able to perform the essential duties of the position, with or without reasonable accommodation. Visit our Applicant FAQs page for helpful information on the application process. Visit our Total Compensation page and this sample for a detailed look into the benefits, awards, leave, retirement, and other incentives employees may receive as part of a rewarding work environment.