The Oncology Research Protocol/Regulatory Coordinator serves as a primary liaison between the Hematology/Oncology and Radiation Oncology Principal Investigators (physicians), study sponsors and Edward Hines Jr. VA Hospital's Research Administration, Institutional Review Board and Safety Committee. The Regulatory Coordinator organizes and prepares new protocols for submission to Research Administration, Institutional Review Board, and Safety Committee for internal and external regulatory reviews.

Duties

Major Duties include, but are not limited to, the following: The incumbent 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. Specific responsibilities include: Electronic submission of new study package per current research procedures, guidelines, Federal regulations, and specific protocol requirements, including, but not limited to: Study protocol (abstract, inclusion criteria, exclusion criteria, risk information, benefits, alternatives to participation, recruitment plan, confidentiality plan, plan for monitoring/reporting adverse events, testable hypothesis/research questions, specific aims/objectives, experimental design/methods and procedures, data/statistical analysis, inclusion/exclusion criteria) Investigator's Brochure Case Report Forms Data Collection Tool Funding information Study personnel form Investigational New Drug application FDA 1572 Form Pharmacy review sign off form Investigational drug form Area sign-off forms 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. Participates in study initiation visits, interim monitoring visits, closeout visits, audits with sponsors Finalization of documents based on IRB comments and recommendations to ensure IRB and R&D approval of a study. Maintenance of regulatory electronic and paper records for an average of 30-35 studies, which includes both actively enrolling and closed studies. Administrative management and electronic submission of approved studies: Preparation and submission of Amendments Preparation and submission of IRB Annual Continuing Review and Annual Safety review Documentation and submission of the following study-related reports to the IRB Committee a. protocol deviation/violation documentation b. DSMB/DMC board meetings and decisions c. Serious adverse events as related to the studies Maintain training records for research staff : CITI Training, Privacy and HIPAA Training, Scope of Practice Maintenance of each study administrative documentation practices Responsibility to prepare and make all source records available for monitoring, auditing, and inspection purposes Knowledge of procedures, documentation systems, and requirements of Principal Investigators, sponsors, and regulatory authorities Investigational product reference materials Understanding of elements of a protocol, Investigator Brochures, or instructions for use Participant safety considerations: Standard of care vs. protocol requirements Safety and expected therapeutic effects of the investigational product Requirements for human subject protections and privacy Principles and content of the key documents ensuring the protection of human participants in clinical research Ethical issue involved when dealing with vulnerable populations and the need for additional safeguards Safety reporting requirements of Hines VA and regulatory agencies both pre- and post-approval Ethical issues as they apply to the clinical research Inclusion and exclusion criteria included in clinical protocols assuring human subject protection Principles and methods of selection and management of clinical trial subjects Blinding procedures Components of subject eligibility requirements Confidentiality and privacy requirements Elements of the Investigator Brochure Informed consent process requirements Subject discontinuation criteria/procedures Subject retention strategies Investigational Product Regulations: Roles and responsibilities of the various stakeholders and regulatory institutions in the ongoing/managed clinical trials and non-interventional protocols Regulations supporting the development and registration of medicines, devices, and biologics SWOG Audit, Hines VA Research Compliance Officer audit, and Monitor visits and inspection processes Clinical trial registries and requirements Knowledge of the IRB role, composition, and purpose Knowledge of the IRB, Safety, and R&D requirements for submission, review, and approval of documents Protocol and protocol amendment submission and approval processes Work Schedule: Monday - Friday, 8:00AM - 4:30PM Telework: Ad-HOC Virtual: This is not a virtual position. Position Description/PD#: Health Science Specialist/PD21125O Relocation/Recruitment Incentives: Not Authorized Financial Disclosure Report: Not required

Requirements

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 08/10/2023. Time-In-Grade Requirement: Applicants who are current Federal employees and have held a GS grade any time in the past 52 weeks must also meet time-in-grade requirements by the closing date of this announcement. For a GS-09 position you must have served 52 weeks at the GS-07. The grade may have been in any occupation, but must have been held in the Federal service. An SF-50 that shows your time-in-grade eligibility must be submitted with your application materials. If the most recent SF-50 has an effective date within the past year, it may not clearly demonstrate you possess one-year time-in-grade, as required by the announcement. In this instance, you must provide an additional SF-50 that clearly demonstrates one-year time-in-grade. Note: Time-In-Grade requirements also apply to former Federal employees applying for reinstatement as well as current employees applying for Veterans Employment Opportunities Act of 1998 (VEOA) appointment. Note: Time-In-Grade requirements also apply to former Federal employees applying for reinstatement as well as current employees applying for Veterans Employment Opportunities Act of 1998 (VEOA) appointment. Basic Requirements:Bachelor's degree 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. (TRANSCRIPT REQUIRED)GS-9 Grade Requirements:Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-07 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: a background of knowledge, skills and techniques gained from professional training in a health science or allied scientific field, familiarity with Institutional Review Board (IRB) paperwork, literature reviews, and data coding, knowledge of research investigatory processes, various data gathering and data management techniques, such as patient interviewing, medical record abstracting, downloading and working with VA administrative databases, data cleaning, coding, and entry and the ability to take this knowledge and integrate it into workable research plans, and skills in managing research settings and coordinating projects (including following protocols, enrolling and interviewing patients, and obtaining informed consent)- Knowledge and experience with human subject research regulatory processes and procedures. OR, Education: Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have 2 years of progressively higher level graduate education leading to a master's degree or master's or equivalent graduate degree. (TRANSCRIPT REQUIRED) OR, Combination: Applicants may also combine education and experience to qualify at this level. You must have an combination of specialized experience and education beyond 1 year of graduate level education. (TRANSCRIPT REQUIRED) Preferred Experience: Knowledge and experience with Human subject research. Knowledge and experience with research both clinical and administrative processes. You will be rated on the following Competencies for this position :ComplianceComputer SkillsCritical ThinkingManages and Organizes Information 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; religions; 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. Note: A full year of work is considered to be 35-40 hours of work per week. 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. 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

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: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html.

Contacts

• Address Edward Hines Junior Hospital 5000 South 5th Avenue Hines, IL 60141 US
• Name: Angela Godbee
• Phone: 706-691-3942
• Email: [email protected]