WVU Online

Clinical Research

• Ensure compliance with current regulations, guidance and policies at the institutional, state, federal, and international levels.
• Assess feasibility of implementing new protocols.
• Collaborate with investigators, research staff, pharmacy, clinical staff and other ancillary departments to implement and conduct trials.
• Facilitate and participate in monitoring or auditing reviews conducted by internal and/or external agencies such as the U.S. Food and Drug Administration, industry, IRB and quality assurance.
• Serve as a liaison between the research team, clinical staff, and sponsors.
• Provide education to staff prior to implementation and throughout the lifecycle of the research study and monitor protocol adherence.
• Support community outreach and trial advocacy.
• Collaborate with research team utilizing internal and external resources to develop a recruitment strategy for each research study and evaluate effectiveness.
• Ensure the initial and ongoing consent process is performed and documented in compliance with all applicable regulations, guidelines and policies.
• Educate patients on trial participation, providing updates and information throughout the lifecycle of the study.
• Assess for barriers to effective informed consent discussion and implement a plan to overcome as barriers are identified.
• Assess eligibility and monitor patient adherence.
• Ensure scheduling and adherence to all protocol tests and procedures.
• Perform study assessments and/or procedures within the employee’s scope of practice which may include but not limited to vital signs, ECG, administering questionnaires, etc.
• Assess and document adverse events in collaboration with the investigator.
• Collaborate with investigator on dose modifications and treatment responses.
• Advocate for ethical care of participants while adhering to the protocol requirements.
• Maintain accurate source documentation and data reporting.
• Provide protocol training to clinical staff and/or other members of the research team.
• Ensure proper documentation practices from clinical staff and provide additional training, as needed.
• Update the Clinical Trial Management System (CTMS) with protocol and patient information.
• Review trial budgets and coverage analyses for adequacy of funding.
• Distinguish between routine care and research-related expenses.
• Ensure patients are reimbursed for research related expenses and/or stipends provided per protocol/contract.
• Participates in educational opportunities to increase knowledge about oncology and clinical research.
• May lead projects or coordinate team efforts.
• Assist with onboarding and training research staff.

Oncology Clinical Research Coordinator – Clinical Research Unit

QA Engineer

• Quality Assurance Auditor Leads collaborations with clinical research teams in non-compliance issue identification.
• Implements monitoring procedures and tools for investigator-initiated (IND) or IDE-enabling clinical trials.
• Conducts and documents assigned periodic monitoring according to the monitoring plan.
• Verifies validity of research results by ensuring timely, accurate, and complete source data and Case Report Form documentation.
• Participates in the preparation and follow-up activities for regulatory agency and Sponsor audits.
• Plans and writes materials for IRB submissions.
• Submits and tracks regulatory documents in the clinical trials management system (CTMS).

Quality Assurance Auditor/Regulatory Associate – Clinical and Translational Science Institute

Frontend Engineer

• The developer reports to the Director of Systems in the WVU Libraries and works as part of the Systems department
• The developer has a strong commitment to user-centered services, web accessibility, improving user experience, and service excellence
• They will inventory and conduct accessibility audits and evaluations of digital content, platforms, and technologies, including websites, digital collections, software tools, documents (PDF, Word, PowerPoint), multimedia, and electronic resources
• They will visualize the results of accessibility audits and usability testing, and make recommendations to improve digital collections, web applications, websites, and services based on accessibility standards and best practices, usability testing data, and market research
• They will review library content and web interfaces and provide feedback to library employees for content creation and remediation based on available tools and resources
• The developer works collaboratively with library faculty and staff and campus partners to use the information gathered through accessibility audits and user testing to design and implement accessible, user-friendly, and intuitive interfaces
• The developer will support the development, implementation, and maintenance of a comprehensive digital accessibility program at WVUL aligned with WCAG 2.1/2.2 AA standards and applicable federal and state regulations (e.g., ADA, Section 508)
• The developer will update and make improvements to WVU Libraries websites, web applications, digital collections, and other web-based resources for improved accessibility, usability, and quality assurance
• They will also conduct usability testing of library websites and applications as needed.

Frontend Web Developer – Libraries

Systems Engineer

• Advise/mentor online doctoral students
• Teach and develop online asynchronous courses
• Engage in research activities
• Participate in departmental initiatives

Part-time Adjunct Instructor – Industrial and Management Systems Engineering

Operations

• Engage existing and new manufacturers state-wide to promote the services of the Industrial Extension Service and the department’s center - the West Virginia Manufacturing Extension Partnership (WVMEP).
• Identify opportunities and generate project proposals for a wide variety of business and manufacturing processes that support the generation of sales, reduction of costs, and development of workforce for clients.
• Lead projects for clients with a specific focus on ISO 9001 quality management systems including developing policies, procedures and critical documentation; conducting internal auditor training; mentoring leadership on data driven decisions; and preparing clients for certification audits.
• Lead efforts to expand and improve service offerings with quality management systems to include identification of continuous improvement opportunities to deliver a more comprehensive package of service offerings (including but not limited to problem solving, root cause analysis, process mapping, etc).
• Lead efforts to build a formal service offering for ISO 14001 including development of systems, procedures, and policies; conducting internal auditor training; conducting gap assessments and preparing leadership for certification audits.
• Maintain channels of communication with clients and the internal team to deliver proposals, projects, and follow up timely and efficiently.
• Maintain current records of client firms, proposals, project status, and timesheets using a PC/Cloud-based customer relationship management system.
• Participate in meetings, conferences and events to support the manufacturing industry.

Operational Excellence Practice Manager – Industrial Extension Engineer, Mining and Industrial Extension

Strategy

• Support manufacturers statewide in identifying business improvement opportunities and promoting the services of the Industrial Extension Service.
• Conduct business evaluations with clients to identify strengths and opportunities for improvement including but not limited to profitability analysis, capacity and capability studies, and potential market expansion.
• Conduct business risk assessments to identify solutions for building stronger business continuity plans and employee succession planning to support workforce retention.
• Develop content for and lead client projects with a specific focus facilitating strategic planning, conducting SWOT or similar business analysis and support client development of short- and long-term business planning.
• Identify opportunities to integrate business and strategy services for the center into other service offerings to build a more comprehensive service package for transformational clients.
• Regularly review educational content and client tools to integrate new methodologies, advancing technologies, and improved delivery of training material.
• Maintain strong channels of communication with clients and the internal team to deliver proposals, projects, and follow up timely and efficiently.
• Provide the highest levels of customer satisfaction to all stakeholders including clients, funding sources, the advisory board, and leadership within the University.
• Maintain current records of client firms, proposals, project status, and timesheets using a PC/Cloud-based customer relationship management system.
• Participate in meetings, conferences and events to support the manufacturing industry.

Business & Strategy Manager – Industrial Extension Engineer, Mining and Industrial Extension

Research Analyst

• Supports original cancer prevention and control research using established scientific methods.
• Serves as a technical resource for data management and statistical analysis.
• Supports and facilitates the planning and execution of a variety of research project types, including descriptive studies, inferential statistics, randomized control trials, case-control studies, clinical quality improvement studies, and others.
• Collaborates with principal investigators and research teams to identify grant opportunities, write research grant applications, and contribute to progress reports and contract documentation and deliverables.
• Designs, implements, and maintains data collection tools for research studies, and documents data collection processes and procedures in written methodology reports.
• Assists with the development and implementation of a strategic plan for tobacco control research at the WVUCI.
• Conducts literature reviews to support research projects and publications and utilizes citation management software to organize references.
• Creates and maintains Institutional Review Board (IRB) protocols to ensure data protection and research activities follow best practices, are conducted ethically, and are compliant with all policies for the responsible conduct of research.
• Disseminates research findings nationally, regionally, and locally through published manuscripts, presentations, research briefs, and other reports.
• Develops and maintains strong collaborative relationships with state and local partners, including healthcare organizations, public health agencies, and community advisory boards.
• Functions as a team member of the Department of Cancer Prevention and Control.
• Conducts special projects as assigned by supervisor or Chair of Cancer Prevention and Control.

Senior Research Specialist – Cancer Prevention and Control

Events

• This position is responsible for supporting ongoing projects for the CHATS (Communicating for Health in Appalachia by Translating Science) Lab and Core in the field of cancer prevention and control with a specific emphasis in cancer communication science.
• The CHATS Core consults with internal and external partners providing; (1) dissemination planning, (2) communication material development, and (3) customized training presentations and workshops.
• The person in this role will gain practical experience in health communication, mixed methods research, social listening, knowledge translation, and dissemination science.
• Participates in the creation and dissemination of cancer information through the development of resources such as handouts, flyers, presentations, internal and external communications, videos, photographs, posters, infographics, social media, websites, etc.
• Monitors and utilizes CHATS project management software, running reports on progress and efficiencies when requested.
• Identifies, develops, and maintains partnerships with strategic stakeholders, community, and professional partners, and various community-based organizations throughout West Virginia, the Appalachian region, and the nation.
• Oversees and directs student volunteers and interns.
• Develops dissemination plans for both internal and external clients.
• Coordinates statewide and regional meetings, trainings, and special events which may include managing the continuing education credit process and other administrative activities related to event planning.

CHATS Program Coordinator – Cancer Prevention and Control

• Guide educators in developing, implementing, and analyzing community research initiatives and projects.
• Facilitating research projects with HSTA high school teachers and their students and the HSTA program.
• Teaching and communicate skills to foster strong partnerships and facilitate research endeavors.
• Organizational, data analysis with effective teaching and communication skills
• Developing research data and collection systems
• Lead large group events and provide effective training.
• Ability to deliver compelling oral and written reports at state and national levels.
• Ability to translate instruct and translate complex topics to high school students

HSTA Community Research Specialist – Health Sciences & Technology Academy

• Provide meaningful strategic and technical expertise to the Associate Director for CCPS and the Institute Director in the areas of cancer prevention and control research administration, project planning, and management.
• Prepare and submit new funding proposals and ensure the continuation of existing programs, grants, and contracts.
• Develop and manage the strategic plan for the CCPS component of the CCSG competitive application, including progress reports and other information requested by the NCI.
• Establish and maintain positive working relationships with CCPS Research Program faculty members and staff at WVUCI and at other cancer centers in the U.S.
• Assist CCPS Research Program members with data collection and data analyses for new and ongoing research projects.
• Provide administrative support (e.g., scheduling, spreadsheet development and maintenance, data management, project management) to CCPS Research Program members to support the development and submission of research grant applications.
• Collaborate with external partners to effectively promote WVUCI and CCPS research initiatives at the state, regional, and national levels.
• Engage with the WVUCI Cancer Biology Research Program and the WVUCI Experimental Therapeutics Research Program to identify opportunities for inter-programmatic collaboration.
• Participate in selected WVUCI disease-oriented groups to stay abreast of clinical trial enrollment and identify opportunities for collaborations between basic research, clinical research, and population science.
• Assist with IRB protocol development and submission.
• Assist with the development of scientific manuscripts, abstracts, posters, and presentations to disseminate CCPS research findings and communicate impact.

Administrative Manager – Cancer Prevention and Control

• Identifies and verifies appropriate clinical source documentation for data reporting
• Coordinates data collection with the clinical research team to facilitate efficient and accurate data reporting and regulatory documentation
• Gathers and extracts patient clinical data for entry into later phase industry and federal sponsor-supplied case report forms
• Ensures timely and accurate completion of case report for review by study sponsor and perform data integrity reviews
• Maintains individual research subject records by obtaining copies of medical records, lab reports, treatment schedules, and other vital protocol-related information
• Updates clinical records for review while subjects remain on study
• Manages backup and data archives
• Assists in the regulatory aspects of protocol, including regulatory document preparation, IRB application preparation, adverse event reporting, and IRB communications
• Maintains knowledge of professional principles, legal and/or reporting requirements affecting clinical data research and management

Data Coordinator

• Provide Space Requests and Space Utilization assistance
• Support the Assistant Director in responding to campus space requests
• Analyze space data, drawings, and verified field conditions
• Help identify available or underutilized space
• Work with departments to define space needs and requirements
• Support the development of proposed space solutions
• Develop test fits and provide documentation analysis and graphics to support data-informed space solutions
• Drafting and Project Drawing Development
• Conduct field verification and measurements to document existing building conditions
• Develop accurate existing-conditions base drawings in Revit and/or AutoCAD
• Support the Space Management group during the annual University Space Audit
• Conduct limited physical space audits as needed
• Update University building floor plan files with Auto CAD
• Support the documentation and maintenance of departmental policies, procedures, and standards

Space & Facilities Planning Specialist – Facilities Operations

• Identifies and verifies appropriate clinical source documentation for data reporting.
• Coordinates data collection with the clinical research team to facilitate efficient and accurate data reporting and regulatory documentation.
• Gathers and extracts patient clinical data for entry into later phase industry and federal (i.e. NCI, Cooperative groups) sponsor-supplied case report forms to measure overall study progress and regulatory documentation compliance.
• Ensures timely and accurate completion of case report for review by study sponsor and perform data integrity reviews of entered data prior to collection and analysis.
• Maintains individual research subject records by obtaining copies of medical records, lab reports, treatment schedules, and other vital protocol-related information.
• Updates clinical records for review while subjects remain on study. Corrects and revises data as appropriate.
• Maintains security and confidentiality of patient/protocol information.
• Manages backup and data archives(files).
• Provides data for audit by outside agencies.
• Assists in the regulatory aspects of protocol, which may include regulatory document preparation, IRB application preparation, adverse event reporting, and IRB communications.
• Abstracts data for clinical research needs. Attends staff meetings as required.
• Maintains knowledge of professional principles, legal and/or reporting requirements affecting clinical data research and management and adheres to industry and government standards.
• Assists and/or follows direction of the Director for professional development and to determine course of customer service.

Data Coordinator – Cancer Institute, Clinical Research Unit

• Prepare financial reports pertaining to the post-award actions for WVUCI CTRU
• Maintenance of accurate and complete financial records/documentation.
• Organizational management of post-award aspects of the clinical trials.
• Assuring billing compliance with Medicare and third party payers associated with CTRU clinical trials.
• Assist with operational WVUCI CTRU budgeting process.
• Assist with pre-award budget development for WVUCI supported projects.
• Processing invoices to sponsors for each study.
• Preparing and processing operating requisitions for each study.
• Maintaining budget and financial records of all clinical trials.
• Completing monthly financial reports for each trial.
• Maintaining accounts, in conjunction with clinical trial coordinators of trial enrollment.
• Reconcile accounts for assigned WVUCI CTRU tasks/projects.
• Post and reconcile transactions with grants and general ledger accounts.
• Reconcile and process payroll with WVURC
• Support faculty and staff with travel settlements, and reimbursement.

Post Award Accountant

• Identifies, develops, and maintains partnerships with strategic stakeholders, community, and professional partners, and various community-based organizations throughout West Virginia and the Appalachian region
• Collaborates with internal and external partners to build capacity to address cancer burden; including assisting with community needs assessments, attending and coordinating community meetings, and providing bidirectional communication
• Conducts, in partnership, at least two monthly community focused cancer control activities in the assigned region
• Responsible for the design, development, and implementation of community outreach and engagement plans for the assigned region
• Coordinates and facilitates internal and external programmatic meetings to monitor progress of projects or initiatives as assigned
• Contributes to the design, implementation, evaluation, and dissemination of innovative, culturally appropriate, evidence-based programs, content, and services
• Provides technical assistance and expertise in program planning, implementation, evaluation, and applied research
• Fosters opportunities for bidirectional research between WVUCI and the community
• Assists with the implementation or recruitment of research projects in the community
• Documents program progress and submits monthly reports, assessing strengths/weaknesses, and develops and implements strategies to improve outcomes and deliverables
• Develops and disseminates cancer information creating resources such as handouts, flyers, presentations, internal and external communications, videos, photographs, posters, infographics, social media, websites, etc. as relevant to both internal and external stakeholders
• Assists with applications for additional funding opportunities for CPC projects
• Participates in the implementation of the mission, vision, and strategic plan for the WVU Cancer Institute and Department of Cancer Prevention and Control
• Develops and delivers presentations on cancer prevention, cancer screening, health literacy, and cultural competency, and others as determined by need
• Serves on local and statewide coalitions and taskforces
• Submits or assists with submission of articles, abstracts, and posters to promote programmatic work, research, and outreach of CPC
• Functions as a member of the CPC staff and participates in regular team meetings, training sessions, program meetings, and others as required