Manager, Clinical Protocol Administration - Goal Concordant CareMission StatementThe mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.about the center for goal concordant care ResearchIndividuals living with advanced cancer often have to confront complex decisions regarding their treatments, preferred care settings, and care philosophy. Unfortunately, many do not fully grasp the gravity of their illness, leading to treatments that are misaligned with their goals. This often results in frequent emergency room visits, avoidable hospitalizations, and aggressive end-of-life measures. Goal concordant care, an institutional priority at MD Anderson, aims at improving communication among patients, caregivers and clinicians, enhancing the quality of life of patients with advanced cancer and their families, and delivering high quality end-of-life care. To address these challenges, MD Anderson has established the Center for Goal Concordant CareResearch. The Center aims to bridge existing knowledge gaps by leveraging cutting-edge scientific advancements to tailor appropriate care interventions for the right patient at the right time.The overarching vision is to establish the Center for Goal Concordant CareResearch as the preeminent international research center revolutionizing the science of person-centered, goal-concordant, and value-based care. Achieving this vision necessitates collaboration with global experts and an unwavering commitment to enhancing the clinical practices of oncology professionals through research and education.The Center for Goal Concordant CareResearch seamlessly aligns with MD Anderson's strategic priorities of expanding its Reach, pursuing Breakthroughs, and delivering Value. Initially, the Center will focus on talent acquisition, expert engagement, and the establishment of operational policies and guidelines. The Center for Goal Concordant CareResearch is expected to accelerate research in patient-clinician communication and supportive/palliative care, ultimately enhancing care for patients with advanced cancer worldwide. This will benefit not only patients but also caregivers, healthcare professionals, and healthcare systems.SummaryThe primary purpose of this position is to provide strategic planning and administrative oversight of the clinical research protocols initiatives and grant applications support for research activities in the Center for Goal Concordant Care Research.Key FunctionsClinical Protocol Administration / Regulatory Compliance 40%Manages clinical research activities including implementation of clinical trials, regulatory compliance, quality assurance, electronic submission of patient data, and resolution of monitor findings. Oversees and coordinates IRB submissions of new and amended protocols for the department, including creation or revision of relevant documents. Work with individual Principal Investigators, administrative assistants and research staff members to ensure that revisions or amendments are submitted and ensures that desired outcomes are reached on a timely basis. Collects and develops criteria information for protocol submission. Develops and manages the department implementation of systems, policies, and procedures affecting the submission, review, approval, activation, regulation, tracking, and reporting of protocols, according to institutional and external requirements. Coordinates and oversees activities associated with study start up and site initiation visits. Ensures proper authorization has been received before new protocols are opened. Assists with continuing reviews and protocol terminations as needed. Audits or coordinates audits of systems and practices to ensure quality and regulatory compliance. Manage the collection and submission of other regulatory documents as needed to ensure the IRB, Sponsor, Cooperative Groups, and other regulatory agencies receive all required paperwork. Acts as the departmental liaison with the various central institutional offices (Office of Protocol Research, Investigational New Drug Office, Consent Editors, Institutional Review Board, etc.) and with external contacts (Pharmaceutical Companies Representatives, Cooperative Group Representatives, and/or other collaborative academic institutions, etc.). Provides recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the need for and importance of regulatory requirements. Ensures compliance with Good Clinical Practice standards and maintains knowledge of clinical trials process.Research Grants, Contracts and Budget Reporting 30%Ensures thorough preparation of study budgets, negotiation of financially sound contracts, and timely tracking and collection of sponsored payments. Develops databases for oversight of protocol budgets, allocated resources (actual salary and effort), and submission of invoicing per protocol. Assists with the sponsor invoicing process for both milestone payments and regularly occurring study visits, to ensure timely collection of payments for work performed. Creates metrics for turnaround times for the various touchpoints in the budget creation and negotiation process for future monitoring. Assists with any departmental needs as required, to include special financial and research reports as requested. Oversees organization and maintenance of sponsored project files relating to fiscal and budgetary responsibilities and report. Consults with departmental finance team regarding expense transactions related to each protocol. Reviews M&O requests through Resource One and other internal departments and programs for allowance on sponsored projects and compares to project budget, contract, and institutional policies. Requests no-cost extensions through grants and contracts.Project Management 20% Attends project meetings and provides input and direction at all phases of projects. Tracks the status of multiple projects within the Center for Goal Concordant Care. Informs key stakeholders of project status including the overall project schedule and resolution of pending issues. Manages project meeting communications in an organized and concise manner while tracking action items and deliverables. Identifies and evaluates potential projects. Partners with center leadership, PIs, and regulatory staff to establish priorities and project schedules.Leadership 10% Serve as the subject matter expert on clinical trial budgeting for the department. In conjunction with department leadership, recruit and train the appropriate staff. Ensures staff attendance at mandatory in-services and compliance with federal and state and accreditation regulations. Recruits, hires, orients and trains the regulatory support staff Completes annual performance evaluations and works with team members to establish annual performance and development goals. Orients new faculty/support personnel on department's clinical trials research infrastructure and procedures. Participates in the development of departmental policies and procedures related to protocol research. Collaborate with leadership in establishing departmental goals, strategies and procedures in support of business objectives. Perform regulatory compliance diligence to support clinical trial goals. Facilitates cohesiveness to improve regulatory compliance consistency and integration of department goals.Other duties as assigned.Education Required - Bachelor's degree in Science, Healthcare, Nursing or related field.Experience Required - Six years of extensive research administrative experience in a biotechnology or academic setting to include two years experience with research protocols, grants and contracts and two years supervisory/management experience. May substitute additional experience for required education (or vice versa) on a one to one year basis.Successful completion of the LEADing Self Accelerate and/or LEADing Self Discover programs may substitute for one year of required supervisory or management experience. Completion of both programs can be substituted for a maximum of two years of supervisory or management experience. Must pass pre-employment skills test as required and administered by Human Resources. It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.htmlAdditional Information
Requisition ID: 168558
Employment Status: Full-Time
Employee Status: Regular
Work Week: Days
Minimum Salary: US Dollar (USD) 80,000
Midpoint Salary: US Dollar (USD) 100,000
Maximum Salary : US Dollar (USD) 120,000
FLSA: exempt and not eligible for overtime pay
Fund Type: Soft
Work Location: Hybrid Onsite/Remote
Pivotal Position: Yes
Referral Bonus Available?: No
Relocation Assistance Available?: No
Science Jobs: Yes
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