Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status.
This position is full-time and works approximately 40 hours per week.
Department Name/Job Location:
This position is in the Department of Neurology/Aging and Dementia/DIAN-TU. This position is for the Medical School Campus.
Position directs daily activities for grants, contracts, funding, and proposal submissions for the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU). The position requires an individual with exceptional analytic, writing, organizational, project management and communication skills.
PRIMARY DUTIES AND RESPONSIBILITIES:
Holds responsibility for day-to-day activities including fiscal and administrative management, contracts and funds, and multicomponent grants and subcontracts.
Coordinate research to design the most effective and efficient trials for dominantly inherited AD (DIAD). Designs, implements, and manages all phases of pre-competitive trial design requiring coordination of expertise from all trial stakeholders (academics, pharma, regulators, NIA, philanthropic funders, patient advocacy groups, and DIAD individuals and families) for initial brainstorming, design vetting and full development of design proposal. Identify new program and collaboration opportunities, and prepare funding proposals for trial design research and implementation of clinical trials in DIAD including multi-component and multi-site grants and contracts. Serves as liaison with funding or sponsoring agency. Track, evaluate, and report progress of projects supporting trial design. Collaborates with other investigators within and external to the university to develop research studies.
Organize and participate in regular international meetings (multiple meetings per year) to coordinate expertise for precompetitive trial design (Pharma, regulators, consultants, researchers, patients, funding agencies, etc.) including development of agendas, coordination of presentation and speakers, assignment and tracking of action items, communications with meeting attendees, distribution of meeting materials.
Manage the DIAN-TU Pharma Consortium.
Primary contact for companies interested in joining the Pharma Consortium
Manages data requests for analyses of DIAN Observational study data to inform on clinical trial design
Ancillary study management and oversight
Manage finances for the DIAN-TU Pharma Consortium activities
Generate and distribute progress reports to the Pharma Consortium members
Organize and plan working group meetings (Trial Design, Biomarkers and Cognitive Endpoint) to vet critical issues related to trial design for DIAD.
Manage the nomination and evaluation process for potential drugs for use in DIAN-TU Clinical Trials.
Develop and maintain forms and procedures including standard operating procedures, Conflict of Interest (COI) management, nomination and evaluation forms, evaluation process, etc.
Identification and invitation of Therapy Evaluation Committee members – ensure committee has appropriate expertise specific to compounds under review.
Execution of CDAs
Coordination of Therapy Evaluation Meetings (agenda, minutes, action item tracking, communicating feedback to Pharma companies, COI management)
Manage completed nomination packets including maintenance of confidentiality of documents and of nominating companies.
Obtaining drug nomination updated information from companies and communicating to Therapy Evaluation Committee members
Primary contact for nominating companies and therapy evaluation activities.
Organize and participate in regular meetings with the company sponsors, consultants and other personnel involved with the projects to track status, ensure issues are addressed and resolved and ensure project goals are met.
Responsible for the development of forms, questionnaires, policies, procedures, and governance for major research committees and leadership structures, etc.
Therapy evaluation: Develop and maintain forms and procedures including standard operating procedures, Conflict of Interest (COI) management, nomination and evaluation forms, evaluation process, etc.
Trial data sharing:
Develop and implement system and process for sharing baseline and post randomization trial data.
Coordinate data request review and approval
Track data transfer and follow-up on data analysis
Ensure communication of data analysis results (publications, presentations, etc.) per study requirements
Development and enforcement of public communication policies and procedures
Review of media releases and public presentations
Communication of media announcements to all stakeholders
Trial-specific policies and procedures
Assures adherence to grant, IRB, and Washington University accounting guidelines for associated grants. Assist DIAN-TU Leadership with regulatory compliance including writing instructional procedure manuals related to trial design and trial implementation activities;
Assist with development and maintenance of Standard Operating Procedures (SOPs)
Participate in quality, operational and financial audits including preparation, presenting/speaking to auditors, and addressing audit findings
Conflict of interest disclosure and management as related to the DIAN and DIAN-TU projects and for Dr. Randall J. Bateman.
Work with WU, pharma, and funding agency media public relations and legal groups to develop and manage press releases and other public communications regarding the trial and other DIAN-TU projects (presentations, interviews, announcements, etc.)
Work with DIAN-TU leadership and Clinical Operations to ensure trial compliance and address issues.
Advises directors on matters of scientific and fiscal concerns.
Primary liaison to PI in developing plans for research projects and discussing the interpretation of results; serves as liaison with funding or sponsoring agency. Collaborates with other investigators within the university to develop research studies.
Project management of DIAN-TU per-competitive trial design and supportive studies including
development and tracking of timelines
coordination with other projects
prioritization of activities.
Coordinate preclinical studies related to DIAN-TU clinical trials to guide trial design
Receive or develop study proposals
Distribute to appropriate stakeholders for review
Distribute and track funding
Track and report progress
Reviews journals, abstracts, and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.
Composes annual solicitation of pilot proposals and project reviews. Assists in the preparation of grant proposals and/or modifications to study design as appropriate.
Draft funding proposals
Prepare all supportive documents and assist with specific aims and research strategy
Ensure completion of documents and application submission
Communicate with and create proposals for non-federal funding agencies (foundations, philanthropy)
Provides projections/recommendations for future resource allocations and scientific directors.
Supervises support staff and advises senior faculty in personnel management. Provides guidance to members of research team in the implementation and evaluation of clinical trial research; trains new staff; may serve as lead or as point of reference for other research coordinators.
Manages administration of shared space, equipment, and furnishings of offices.
Prepares and maintains minutes from Executive Committee meetings, formal voting procedures, and committee activity related to proposals, ensuring follow up on decisions made.
Provides planning and coordination of meetings and schedules presentations for team training.
Establishes/enhances community and donor contacts’, and contact with other centers to facilitate collaboration and exchange of information. Write and negotiate contracts (in concert with appropriate university offices, e.g. MTAs, performance site subcontracts) to ensure research goals:
pharma collaborator contracts
trial vendor contracts
consultant agreements for trial design
CDAs for new pharma collaborators, therapy evaluation committee members, pharma consortium members, vendors, consultants and other collaborators as needed
Pharma Consortium term agreements
Participates in project review meetings and report preparation and analysis. Evaluates and interprets collected clinical data in conjunction with PI as appropriate; prepares oral and written presentations or reports and analyses setting forth progress trends and provides recommendations or conclusions of the same. Collaborates in the preparation of manuscripts for publication.
Prepares and maintains DIAN-TU related presentations
Assists in the development of DIAN-TU related manuscripts
Manages and tracks DIAN-TU related presentations and manuscripts/publications by external groups
Ensures appropriate acknowledgement of related grants
Ensures publication upload to NIHMS system and a PMCID number is generated
Equivalent of a Bachelor’s degree with 5 years related experience.
Scientific professional degree (bachelors or masters degree of science, pharmacology or engineering)
Experience in managing aims and goals of large, complex efforts
Experience in clinical research design, analysis, and execution
Experience with writing protocols, agenda and action plans
Critical thinking and problem solving
Expert communication, interpersonal and organizational skills
Excellent scientific writing skills; knowledge and application of the scientific method
Moderate to advanced computer skills in standard office software (Microsoft Word, Excel, Powerpoint, MS Project)
Able to work independently and as part of a team
Expertise in Gantt charts, resource management
Demonstrated ability and expertise in project management and handling varied aspects of grant administration and management
The hiring range for this position is $46,113 - $58,801 annually.
The DIAN-TU designs, develops and manages therapeutic trials for individuals with and at risk for dominantly inherited AD (DIAD) through the management of the DIAN-TU Pharma Consortium (a group of international pharmaceutical companies working together to design trials for DIAD), evaluation of therapeutic compounds, development and management of the DIAN Expanded Registry (an international registry of individuals with and at-risk for DIAD), support of ancillary studies and implementation of therapeutic trials. The DIAN-TU will be the coordinating center for major drug trials for the prevention of Alzheimer’s disease, funded through a partnership between Washington University, the National Institutes of Health (NIH), pharmaceutical companies, patient advocacy groups, and philanthropic foundations (expected total costs of >$100 million). Continual interaction with NIH, pharmaceutical companies, the Alzheimer’s Association national office, philanthropic funders, and multiple offices within Washington University will be part of this position.
-Retirement Savings Plan -22 vacation days -8 Paid Holidays -Sick Time -Tuition benefits for employee, spouse and dependent children -Free Metro Link/ Bus pass -Free Life Insurance -Health, Dental, Vision -Health Savings Accounts (HSA) -Long Term Disability Insurance -Flex Spending Plan -Other Benefits
Med School HR website (medschoolhr.wustl.edu)
Internal Applicant Instruction:
This position is grade G10.
Please attach a copy of your most current signed performance evaluation (completed within the last 18 months) to your online account. If you have not received a performance evaluation, you may provide two current signed letters of recommendation (written within the last 18 months), preferably to include one letter from either a current or recent former supervisor. To attach these documents, go to: My Career Tools, Add Attachment, Attachment Type – Performance Reviews or Letters of Recommendation.
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