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)

Duties

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

• 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.
• Position requires Education.

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/12617660

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: David Wittenberg
• Phone: 301-451-1828
• Email: [email protected]