Directs the operational review and approval process for research studies submitted to Parkland Health and Hospital System. Directs the Research Administration strategy and processes for operational, financial, regulatory and patient safety review of proposed research studies. Directs a team of analysts to review research study clinical, operational, and billing feasibility to determine approval or non-approval of Parkland as a performance site. Leads collaborative relationships with research investigators and study teams, including focused support for oncology research.
Bachelor's Degree in nursing or a healthcare-related field required.
Master's degree in Business Administration, Nursing or health-related field preferred
Completion of formal training in nursing required. An active nursing license preferred.
Must have five years of experience in the management and administration of research studies or programs and interdisciplinary teams.
Must have experience with clinical trial coverage analysis and clinical trial billing.
Must have clinical trial coordination experience.
Experience with research and the electronic medical record preferred. Familiarity with oncology clinical research preferred.
Equivalent Education and/or Experience
May have an equivalent combination of education and experience to substitute for the education and experience requirements. Four years of experience in healthcare or clinical research may substitute for the Bachelor's Degree requirement. Six years of experience in healthcare or clinical research may substitute for the Master's Degree preference.
Must have Federal Emergency Management Administration (FEMA) course certification for IS-700.B: An Introduction to the National Incident Management System (NIMS) or obtain within 30 days of placement in role.
Must have Federal Emergency Management Administration (FEMA) course certification for IS-100.C: Introduction to the Incident Command System (ICS 100) for Healthcare/Hospitals or obtain within 30 days of placement in role.
Must have Federal Emergency Management Administration (FEMA) course certification for IS-200.HCA: Applying ICS to Healthcare Organizations (ICS 200) or obtain within 30 days of placement in the role.
Required Tests for Placement Skills or Special Abilities
Must have knowledge of laws, rules, regulations, policies, and guidelines that impact the conduct of research.
Must have knowledge of Institutional Review Board regulations, processes, and practical application of those processes.
Ability to develop or verify a clinical trial coverage analysis that reflects the study protocol, consent form, and clinical trial agreement.
Ability to evaluate the impact of research requirements on health care delivery in the clinic, hospital, or other health system setting.
Must have a broad knowledge of clinical trial operations, budgets, clinical trial billing, and research agreements.
Must have a broad knowledge of ICH, GCP, privacy, security, other federal and state laws, regulations, and guidelines, and how they apply to clinical trials.
Must have the ability to handle sensitive and confidential information.
Must be able to work in a productive and collegial manner with external research partners.
Must be able to demonstrate initiative, independent problem solving, organization, and time management skills.
Must be able to demonstrate strong leadership, project management, teamwork, negotiation, customer service, and interpersonal skills.
Must have excellent written and verbal communication and presentation skills.
Ability to effectively use Microsoft applications such as Word, Excel, and PowerPoint.
1. Oversees the clinical, operational, regulatory, ethical, and financial review and approval process for clinical research studies submitted to Parkland Health and Hospital System.
2. Provides guidance to the research community regarding processes, resources, and costs associated with the conduct of research at Parkland.
3.Develops and oversees processes at Parkland for validating or performing a coverage analysis, identifying/documenting research billable items, and developing appropriate billing agreements with sponsors or external research partners.
4. Assists in the development and oversight of processes for identifying research participants and research-related charges and ensuring proper routing of research charges.
5. Works collaboratively with key individuals and committees in Parkland Pharmacy (Investigational Drug Service), Pathology, Radiology, IT, Procurement, Legal, PFS, and Clinical Departments to develop processes for implementation of research studies.
6. Assists with the collection, classification, interpretation, and dissemination of data regarding research performed at Parkland and performance metrics for the Research Administration department.
7. Assists with evaluating and implementing new software to support Research Administration Department operations and investigator research proposals.
8. Assists in representing Research Administration in the development of research functionality and reporting in EPIC.
9. Leads initiatives to create, coordinate, and streamline research services.
10. Works collaboratively with external research partners to develop effective processes for routing of research proposals, ensuring adequate coverage analyses, ensuring IRB review and approval, communicating study regulatory requirements, and communicating Parkland operational and resource utilization requirements.
11. Provides support and input to the Parkland Research Committees and to other medical, operational, or department committees that include representation from the Office of Research Administration.
12. Assists the Vice President, Office of Research Administration, in developing strategies, plans, analyses, policies, procedures, work plans, timelines, and presentations to address research issues, convey information about new initiatives and represent Parkland to the institution and the research community.
Identifies and analyzes the design of jobs, work processes, workflows, etc. for the area and implements appropriate changes to improve effectiveness, productivity, and efficiency that support the overall goals of the department and Parkland.
Stays abreast of the latest developments, advancements, and trends in the field by attending seminars/workshops, reading professional journals, actively participating in professional organizations, and/or maintaining certification or licensure. Integrates knowledge gained into current work practices.
Maintains knowledge of applicable rules, regulations, policies, laws, and guidelines that impact the area.
Develops effective internal controls designed to promote adherence to applicable laws, accreditation agency requirements, and federal, state, and private health plans. Seeks advice and guidance as needed to ensure proper understanding.
Develops and monitors annual budgets that ensure the department has the necessary funds to carry out the goals and objectives that have been established for the department. Develops, implements, monitors, and revises annual goals and objectives for the department that support the missions and objectives of Parkland.
Selects, trains, schedules, motivates, supervises, and evaluates employees making recommendations for disciplinary actions up to and including termination, to ensure maximum utilization of individual and group capabilities. Ensures that assigned employees receive opportunities to further their knowledge.
Parkland Health and Hospital System prohibits discrimination based on age (40 or over), race, color, religion, sex (including pregnancy), sexual orientation, gender identity, gender expression, genetic information, disability, national origin, marital status, political belief, or veteran status.
Nearest Major Market: Dallas
Nearest Secondary Market: Fort Worth
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