NIH is looking for protocol navigators who help principal investigators with the development of the research protocols from concept to initial approval and through the life cycle of protocols from a broad range of medical specialties. As protocol navigators, you will manage IRB submissions of research studies and collaborate with internal and external study team members, so please describe your experiences coordinating IRB submissions and facilitating IRB approval of submissions in your resume.

Duties

Serving as an advisor to investigators regarding protocol development and coordinates the protocol development and implementation support for an assigned portfolio of clinical trials. Preparing all documents for amendment submissions to the IRB including the changes to the protocol and cover memo detailing the changes. Assisting investigators with maintaining protocol applications within the protocol management database system. Providing the Principal Investigator with information concerning services provided and support needed for each protocol that includes: protocol/IC development, statistical support, and scientific review submission requirements. Orchestrating meetings with Principal Investigators (PIs) and other key research staff to identify the level of support needed and creates timelines and manages protocol start-up logistics. Reviewing packages for IRB submissions such as initial reviews, continuing reviews, amendments and problem reports for compliance with regulatory and institution requirements and ensuring the action is complete prior to submission. Working closely with the Institutional Review Board (IRB) to keep abreast of new guidance related to protocol and informed consent submission for both initial reviews and amendments, and shares relevant information with team members. Maintaining study regulatory documents in accordance with departmental, organizational and federal policies. Acting as liaison between various stakeholders during study approval process.

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 the pre-appointment process (i.e., background investigation, verification of qualifications and job requirements, completion of onboarding forms, submission of required documents, etc.)
• Males born after December 31, 1959 must be registered with the Selective Service.
• Applicants must meet all qualifications requirements within thirty (30) calendar days of the closing date of this announcement, including time in grade.
• This position is designated as an "non-emergency/teleworker" position. See definition of this designation in the Additional Information Section of this announcement.
• If selected, you must pass a pre-employment medical examination, provide evidence of immunization, and be free from communicable diseases.
• At the supervisor's discretion, this position may offer work schedule flexibilities: Maxiflex schedules and Telework.

Qualifications

You qualify at the GS-11 level, if you meet one (1) of the following qualification requirements: A. Have completed a Ph.D. or equivalent doctoral degree, or 3 full years of progressively higher level graduate education leading to such a degree or an LL.M., if related; OR B. Have 1 year of specialized experience equivalent to at least the GS-9 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: assisting principal investigators in writing and/or revising clinical research protocols and informal consent forms; providing guidance to principal investigators on clinical research trial regulations and policies; tracking IRB approvals via an automated protocol database; maintaining regulatory or compliance documentation for the protection of research subjects and the organization; and providing consultation to principal investigators, organizational leadership, and staff on intramural research protocols and procedures. OR C. Have a combination of post baccalaureate education related to the position and experience that meets 100% of the qualification requirements for this position. You qualify at the GS-12 level, if you meet the following qualification requirement: You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-11 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: assisting principal investigators in writing and/or revising clinical research protocols and informal consent forms; preparing clinical protocol research amendment and change related documentation; monitoring human subject activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies; developing guidance to improve the effectiveness of the research protocol implementation process and reviewing initial clinical protocol applications for adherence to for appropriate regulatory and monitoring bodies/boards compliance requirements. 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. 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. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12112086

Education

If you qualify based on education in lieu of specialized experience, 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 packages. 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 Dr Bethesda, MD 20892 US
• Name: Jacaranda Guzman Vargas
• Phone: 301-594-3862
• Email: [email protected]