Employee will be assigned to Hematology/Oncology, VA Hospital, Hines, IL, serving as the Oncology Research Protocol/Regulatory Coordinator. The Health Science Specialist organizes and prepares new protocols for submission to Research Administration, Institutional Review Board (IRB), and Safety Committee for internal and external regulatory reviews to secure the approval of clinical research while ensuring the protection of human subjects' safety, rights, and welfare.

Duties

***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION*** Duties include, but may not be limited to the following: Interprets and applies rules and regulations and is responsible for submission, documentation, and administrative reporting of study activities throughout the duration of the project with emphasis on regulatory compliance. Performs electronic submission of new study packages per current research procedures, guidelines, Federal regulations, and specific protocol requirements. Has responsibility for regulatory submissions to study sponsors including Federal Drug Administration (FDA), financial disclosures and coordination of IRB documents, investigator and staff training logs, and other study start-up documents as needed, to ensure study start-up. Finalizes documents based on IRB comments and recommendations to ensure IRB and Research and Development approval of a study. Maintains regulatory electronic and paper records of studies, which includes both actively enrolling and closed studies. Maintains training records for research staff. Carries out administrative management of approved studies. Maintains participant safety following protocol requirements. Performs other related duties as assigned. Work Schedule: Monday - Friday, 8:00am - 4:30pm. Recruitment & Relocation Incentives: Not authorized Financial Disclosure Report: Not Required

Requirements

Qualifications

BASIC EDUCATION REQUIREMENT - Applicants must possess a Bachelor's 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 (external link) at the time the degree was obtained. (TRANSCRIPT REQUIRED) This position includes a Selective Placement Factor (skill, knowledge, ability or other worker characteristic basic to - and essential for - satisfactory performance of the job). Selective Placement Factors are a prerequisite to appointment and represent minimum requirements for a position. Applicants who do not meet it are ineligible for further consideration. The Selective Placement Factor for this position is: Must have experience working with human subjects' research regulatory processes and procedures. ADDITIONAL QUALIFICATION REQUIREMENTS - In addition to meeting the above requirements, you must also meet one of the additional requirements as described below to qualify for this position. SPECIALIZED EXPERIENCE: Applicants must have at least one (1) year of specialized experience that equipped them with the particular knowledge, skills, and abilities to perform successfully the duties of this position. To be creditable, this experience must have been equivalent to at least the GS-7 level in the Federal service. Specialized experience includes: experience carrying out the principles and practices of health services research; interpreting and applying rules and regulations for clinical research studies; submitting research study/research packages for higher level review; coordinating and submitting Institutional Review Board (IRB) documents; and maintaining research study related reports and records. OR SUBSTITUTION OF EDUCATION FOR EXPERIENCE (TRANSCRIPT REQUIRED) - Successful completion of 2 full years of progressively higher-level graduate education leading to a master's degree or master's or equivalent graduate degree with a in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position to substitute for the one year of experience, is fully qualifying for the GS-9. OR COMBINING EDUCATION AND EXPERIENCE (TRANSCRIPT REQUIRED) - Combination of successfully completed graduate education and experience may be used to meet total qualification requirements. You will be rated on the following Competencies as part of the assessment questionnaire for this position: ComplianceComputer SkillsCritical ThinkingManages and Organizes Information IMPORTANT: A full year of work is considered to be 35-40 hours of work per week. All experience listed on your resume must include the month and year start/end dates. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. Physical Requirements: The work is sedentary. There may be some walking, standing, bending, and carrying of light items. For more information on these qualification standards, please visit the United States Office of Personnel Management's website at https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/.

Education

IMPORTANT: A transcript must be submitted with your application if you are basing all or part of your qualifications on education.

NOTE: Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. You can verify your education here: http://ope.ed.gov/accreditation/. If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education. For further information, visit: Recognition of Foreign Qualifications | International Affairs Office (ed.gov).

Contacts

• Address Edward Hines Junior Hospital 5000 South 5th Avenue Hines, IL 60141 US
• Name: VHA National Recruitment Center
• Phone: (844)456-5208
• Email: [email protected]