This position is located in the Clinical Trials Program (CTP), Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), U.S. Department of Health and Human Services (DHHS).

Duties

PRINCIPAL DUTIES AND RESPONSIBILITIES: As a Protocol Specialist in VRC/CTP, you will perform a wide range of protocol development/operations, clinical data management, study documentation, and collaborative tasks and assignments that typically include, but are not necessarily limited to, the following: Apply policies, procedures, rules, and regulations concerning clinical research to protocol development and implementation. Produce high-quality clinical trial protocols for evaluation of VRC products that communicate the strong scientific basis for conducting the study, while also ensuring that ethical and regulatory requirements are met and that the study is logistically feasible to conduct at the clinical site. Develop clinical trial protocols, consent forms, and related documents; ensure they address scientific objectives and meet standards for human subjects protection. Conduct protocol background research, interpret scientific and technical information, edit protocol documents for accuracy, completeness, and internal consistency; guide the protocol through the review process. Use information technology/telecommunication systems for data management and document control. Collaborate with VRC principal investigators, study coordinators, and other study personnel, as needed, to devise and implement protocol-specific data collection and reporting plans.

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 qualification requirements by the closing date of this announcement.
• Males born after December 31, 1959 must be registered with the Selective Service.
• Position requires Education - submission of transcripts are highly encouraged.

Qualifications

You qualify at the GS-13 level, if you meet the following qualification requirements: You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: managing clinical trial protocol development and operations for candidate vaccines and monoclonal antibodies; preparing clinical trial protocols and associated documentation and communications; managing clinical data and documentation control for clinical protocols; and developing and maintaining databases and tracking systems for research protocols and clinical data management. AND EDUCATION Completion of a Bachelor's or graduate/higher level degree 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(external link) at the time the degree was obtained. 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. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12303088

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: Teresa Collins
• Phone: 301-761-5348
• Email: [email protected]