This position is located within the Oncology Research Protocol/Regulatory Coordinator office at the Edward Hines, Jr VA Hospital in Hines, IL. The Health Science Specialist organizes and prepares new protocols for submission to Research Administration, Institutional Review Board, 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*** Some of the duties and responsibilities of this position include (but are not limited to): Perform electronic submission of new study package per current research procedures, guidelines, Federal regulations, and specific protocol requirements. Responsible for regulatory submissions to study sponsors including FDA 1572, 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. Finalize documents based on IRB comments and recommendations to ensure IRB and R&D approval of a study. Maintain participant safety considerations. Maintain regulatory electronic and paper records for an average of 30-35 studies, which includes both actively enrolling and closed studies. Maintain training records for research staff. Perform other related duties as assigned. Work Schedule: Monday-Friday, 8:00 am - 4:30 pm Recruitment & Relocation Incentives: Not authorized Financial Disclosure Report: Not Required

Requirements

Qualifications

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: Do you possess knowledge and experience with human subject research regulatory processes and procedures? AND BASIC EDUCATION REQUIREMENT: You must have successfully completed 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 this 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. The number of semester hours required to constitute a "major" field of study is the amount specified by the college or university attended; If this number cannot be obtained from the transcript, 24 semester hours will be considered as equivalent to a major field of study. (TRANSCRIPTS REQUIRED - If you do not submit a copy of your transcript, your application may not be processed.) In addition to the above, applicants must also possess at least one of the following minimum qualifications: SPECIALIZED EXPERIENCE: Possess at least one year of specialized experience that equipped you with the particular knowledge, skills and abilities to perform successfully the duties of this position. To be creditable, specialized experience must have been equivalent to at least the GS-7 grade level in Federal service. Specialized experience includes: interpreting and applying rules and regulations; submitting study and research packages; maintaining study related reports and records. Your skills must be documented in your resume to receive full credit. -OR- EDUCATION: Successfully completed two years of progressively higher level graduate education leading to a master's degree or master's or equivalent graduate degree that provided the knowledge, skills, and abilities necessary to do the work of this position. Transcripts must be submitted with your application materials. Education cannot be credited without documentation. -OR- COMBINATION: Possess equivalent combinations of successfully completed graduate education (beyond the first year) and specialized experience, as described above, to meet total qualification requirements. The education portion must include courses that provided the knowledge, skills, and abilities necessary to do the work of this position. Transcripts must be submitted with your application materials. Education cannot be credited without documentation. 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]