Clinical Trials Specialist

Summary Do you have experience in the management and oversight of ethical, regulatory, and safety aspects of observational studies and clinical trials? Multiple Clinical Trials Specialist positions are available in the following Divisions in the National Heart, Lung, and Blood Institute: Division of Blood Diseases and Resources (DBDR) Center for Translation Research and Implementation Science (CTRIS) Responsibilities As a Clinical Trials Specialist, you will: Effectively establish overall priorities for the oversight of clinical trials, monitoring performance and providing guidance. Plan, develop, and implement targeted research programs. Manage protocol development for clinical studies supported by the Division. Ensure protocol compliance with guidelines (e.g., inclusion of women, minorities and children in clinical research; reporting adverse events, etc.). Develop protocol budgets as needed. Collaborate with the Data Coordinating Center (DCC) to prepare Manuals of Operation and other study documents such as recruitment brochures, website content, etc. Review adverse events, adverse events files, and reports and analyses; ensuring timely and accurate evaluation and reporting of adverse events in accordance with NHLBI policy. Use clinical judgement, and in consultation with medical officers, assess possible risks for patient safety, evaluate adequacy of safety data collection and management, and recommend and implement remedial action or propose new scientific study. The incumbent is under closer supervision and receives more detailed instructions at the GS-12 level. As the incumbent progresses, the complexity and pace of the duties increase and the incumbent will work with greater independence. This position has a full performance level of GS-13. Requirements Conditions of Employment Qualifications Basic Qualifications In order to qualify for a Clinical Trials Specialist, GS-0601 position: You must have 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. Additional Qualifications In order to qualify for a Clinical Trials Specialist, GS-0601 position at the GS-12 level, you must have 1 year of 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: preparing comprehensive reports summarizing the progress on clinical trials; conducting clinical trials and targeted research programs; and assisting with protocol development, implementation, clinical site monitoring, and contributing to the presentations of clinical research. In order to qualify for a Clinical Trials Specialist, GS-0601 position at the GS-13 level, you must have 1 year of 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: performing oversight and management pertaining to the regulatory and procedural aspects of clinical research/clinical trials; developing protocol budgets; managing protocol development for clinical studies and monitoring performance; directing the development and maintenance of standard operating procedures for adverse event data collection; and establishing overall priorities for the oversight of clinical trials and performance evaluation. 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/12608642 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. At the supervisor's discretion, this position may offer work schedule flexibilities: [telework (work from home on a regular basis or ad hoc basis but reports to the office at least once a week/two days a pay 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 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. 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. If selected, you may be eligible to receive a salary above the minimum based on superior qualifications and/or a special need of the Government for your services. This applies to employees paid under the General Schedule (GS) and Federal Wage System (FWS) pay systems and is at the discretion of the hiring manager. A salary above the minimum must be approved before the appointment.