This position is located in the Office of Sponsor and Regulatory Oversight (OSRO), Office of Clinical Director (OCD), Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH), Department of Health and Human Services (HHS).

Duties

Managing all Sponsor clinical operations obligations as listed in ICH GCP E6 section 5. Managing all Sponsor activities for sites assessment, initiation, activation and close out. Developing SOPs and processes in support of those actives. Serve a supervisor for the clinical operation team and serve as the COR or COR representative for OSRO support contract. Providing expert guidance to investigators, team members, and pharmaceutical partners, on clinical operations to support clinical trials in new and commercial drugs and devices used in the treatment of cancer. Providing expert guidance to investigators, team members, and pharmaceutical partners to ensure IND/IDE study protocols, reports, and documentation conform to applicable guidelines and regulations. The candidate must remain current on trends and patterns in the health sciences/allied science and medical research fields and regulations governing IND/IDEs. Reviews, adverse drug reaction reports to determine the implications for current and planned research, and initiates necessary actions, including modification of specific protocol and overall drug development plans. Provides leadership and direction for the following functions of the OSRO: Protocol Development and Review; Development, Support, and Oversight of Clinical Trial Procedures; Training and Quality Assurance Functions; and Liaison, Coordination, and Advisory Functions.

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.
• Position requires Education. Please submit transcript(s).
• A one-year supervisory trial/probationary period may be required upon selection/placement.

Qualifications

In order to qualify for a Supervisory Regulatory and Clinical Operations Specialist, GS-0601, position you must have successfully 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). In addition, in order to qualify for a Supervisory Regulatory and Clinical Operations Specialist, GS-0601-15, you must have at least one year of qualifying specialized experience equivalent to at least the GS-14 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks:1) Providing operational expertise in the oversight of a clinical research portfolio, including identification and resolution of clinical monitoring issues, safety oversight issues and day-to-day research management issues; 2) Managing and evaluating a portfolio of multi-center or other clinical trials to determine the safety and efficacy of agents or interventions being evaluated; 3) Managing clinical monitoring and safety oversight activities to ensure that clinical trials are conducted in accordance with regulations (e.g., Good Clinical Practice, Human Subjects Protection and FDA regulations); AND 4) Providing training and guidance to clinical site staff about protocol procedures and compliance with regulatory and good clinical practice standards. 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/12281955

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: Jamie Hammond
• Phone: 301-496-5901
• Email: [email protected]