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. 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 Practical knowledge of the following aspects of each managed study: 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, 8:00 AM - 4:30 PM CST Telework: Not Available Position Description/PD#: Health Science Specialist (Oncology Research Protocol/Regulatory Coordinator)/PD21125O Relocation/Recruitment Incentives: Not Authorized Financial Disclosure Report: Not required
Providing Health Care for Veterans: The Veterans Health Administration is America’s largest integrated health care system, providing care at 1,255 health care facilities, including 170 medical centers and 1,074 outpatient sites of care of varying complexity (VHA outpatient clinics), serving 9 million enrolled Veterans each year.