(Hybrid) Manager and Clinical Research Specialist, Mobile Clinical Research - Clinical and Translational Science Institute

The Clinical and Translational Science Institute at West Virginia University is currently accepting applications for a (Hybrid) Manager and Clinical Research Specialist, Mobile Clinical Research.

About the Opportunity

The purpose of this position is to direct the development, implementation, and management (with multiple internal and external partners) of the West Virginia Clinical and Translational Science Institute (WVCTSI) Clinical Trials Center of Excellence (COE)'s Mobile Clinical Trials Unit (MCTU). The MCTU mission is to bring clinical trials and studies to rural West Virginia residents. This program will serve all of West Virginia and require in-person and virtual communications with multiple state and local partners and stakeholders. This position is responsible for long and short-term MCTU planning as well as day-to-day operations. Critical to the success of this position will be the ability to work with a variety of stakeholders to increase participation of West Virginia residents in research and to superbly manage staff and scheduling such that timelines and performance targets are met. The position also requires coordination of clinical trials and studies through duties of a Clinical Research Specialist. The majority of clinical study coordination duties will be conducted on the MCTU, however other clinical studies may be assigned. The individual participates in the development, coordination, and implementation of research and administrative strategies essential to the successful management of Phase II/III/IV clinical trials research conducted by faculty at West Virginia University Health Sciences Center. There are a variety of independent and collaborative duties involved in clinical trial coordination and implementation including organization, oversight, documentation, tracking, data abstraction and collection and compilation of clinical research data. The position will report to the WVCTSI's Clinical Trials Center of Excellence Director.

• 37.5-hour work week
• 13 paid holidays (staff holiday calendar)
• 24 annual leave (vacation) days per year (employee leave)
• 18 sick days per year (for when you're ill, for when you need time to care for sick family, for your own, or your family's, regularly scheduled medical appointments. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof)
• WVU offers a range of health insurance and other benefits
• 401(a) retirement savings with 6% employee contribution match, eligibility to continue health insurance, and other retiree perks. Looking for more retirement benefits information? Check out retirement health insurance benefits, retirement income, and FAQ's.
• Wellness programs

What You'll Do

• Mobile Clinical Trials Unit Manager Duties:
  
  
  
  • Develop, implement, and manage policies and procedures for the Mobile Clinical Trials Unit.
  • Manage the design, development, and implementation of materials to support the mobile unit.
  • Manage internal and external partnerships to advance and monitor progress on the clinical trials implemented on the mobile unit by identifying, assigning, prioritizing and tracking specific assignments/projects.
  • Troubleshoot to develop creative solutions to high-profile problems or concerns with projects and mobile unit scheduling.
  • Direct project staff and ensure that daily work aligns with the needs, overall aims and mission of the project.
  • Supervise the mobile unit driver to ensure operational on-site activities, vehicle maintenance, insurance, and cleaning are maintained.
  • Strategically develop the schedule factoring in complex nuances from internal and external sources while balancing demand with program efficiency.
  • Collaborate with communications staff in the development of resources to promote the program including, but not limited to, internal communications, communications with partners, health education materials, visual media (films, video, photographs, infographics, posters, etc).
  • Actively participate in writing of reports, journal articles or other documentation of project/project program status and project results.
    
  • Travel independently through the state to represent the MCTU, promote education about open clinical trials, and steps to host the mobile unit in local communities.
    
  • Review patient and clinic/partner satisfaction surveys and other evaluation tools and implement quality improvement strategies to address any issues.
    
  • Collaborate regularly with project teams and staff to develop and execute cohesive strategies to advance the clinical trial implementation success, while fostering a positive work environment.
    
  • Network with other mobile unit teams to share and learn best practices. Represent WVU/WVCTSI at regional/national meetings to represent mobile unit
  
  
  
  
• Clinical Research Specialist Duties:
  
  
  
  • Protocol Compliance: Facilitates compliance with the requirements of the research protocol and good clinical research practice while remaining cognizant of the needs of patient populations.
  • Clinical Trials-Related Communication: Utilizes multiple communication methods to facilitate the effective conduct of clinical trials.
  • Informed Consent Process: Demonstrates leadership in ensuring patient comprehension and safety during initial and ongoing clinical trial informed consent discussions.
  • Management of Clinical Trial Patients: Involves a variety of resources and strategies to manage the care of patients participating in clinical trials, ensuring compliance with protocol procedures, assessments, and reporting requirements as well as management of symptoms.
  • Documentation: Provides leadership to the research team in ensuring collection of source data and completion of documentation that validate the integrity of the conduct of the clinical trial.
  • Patient Recruitment: Utilizes a variety of strategies to enhance recruitment while being mindful of the needs of a variety of patient populations.
  • Ethical Issues: Demonstrates leadership in ensuring adherence to ethical practices during the conduct of clinical trials in order to protect the rights and well-being of patients and the collection of quality data.
  • Financial Implications: Identifies the financial variables that affect research and supports good financial stewardship in clinical trials.
  
  
  
  

Manager and Clinical Research Specialist, Mobile Clinical Research

• Master's degree in public health, health sciences, health communications, or a related field.
• A minimum of two (2) years of experience in the following:
  
  
  
  • Experience in public health, community outreach, and/or clinical research, community/practice-based participatory research.
  
  
  
  
• Any equivalent combination of related education and/or experience will be considered.
• All qualifications must be met by the time of employment.

Knowledge, Skills and Abilities

• High degree of creativity and self-motivation.
• Substantial ability to work both independently and cooperatively with others.
• Ability to manage multiple projects concurrently.
• Ability to combine pieces of information to form general rules or conclusions.
• Ability to recognize when something is wrong or is likely to go wrong.
• Skilled at developing and managing relationships with a variety of communities and individuals.
• Experience and skilled in standard office computing and computer software applications (e.g., Microsoft Office applications particularly including Outlook, Word, Excel, and PowerPoint).
• Skilled in identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
• Skilled in monitoring and assessing performance of yourself, other individuals, or organizations to make improvements to take corrective action.
  
• Skilled at building and maintaining positive relationships with faculty, staff, and administrators involved in sponsored research.
  
• Skilled in using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• Skills in, or knowledge of, professional principles, legal and/or reporting requirements affecting extramurally sponsored projects.
  
• Skilled at operating effectively in a fast-paced, high-volume environment & meet deadlines.
  
• Skilled to prepare comprehensive reports and present ideas clearly and concisely.
• Proficient in the latest Microsoft applications such as Word, Excel, Adobe conversions and other related applications.
• High-level oral and written communications skills necessary to explain complex guidelines to appropriate management staff, to justify recommendations, and to interact with regulatory agencies and auditors.
• Ability to read and interpret documents such as program solicitations, form instructions, manuals, etc.
  
• Skilled in speaking effectively before groups of customers or employees of the organization.
  
• Ability to perform simple calculations in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to understand and create spreadsheets.
• Proficient in basic understanding of research design(s) and descriptive and inferential statistics, in order to interpret & communicate findings of CTSI-related research.
• Ability to interpret peer-reviewed scholarly work based on significance and approach (theoretical & analytical).
• Skilled at conducting literature reviews of existing scholarly work in areas related to the CEO mission and aims.
• Able to identify deadlines and schedule work to ensure that deadlines are met.
• Knowledge of clinical trials research.
• Must possess and apply knowledge of many different and unrelated processes and methods related to such areas as:
  
  
  
  • Patient care - information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
  • Treatment design, administration and modification.
  • Counseling and education - principles and methods for training design, teaching and instruction for individuals and groups, and the measurement of training effects.
  • Data collection, validation, entry, analysis, and reporting.
  • Human subjects protection and related issues - knowledge of professional principles (GCP and IRB guidelines), legal and/or reporting requirements affecting grants and contracts and adheres to industry and government standards.
  
  
  
  

• Valid US driver's license.
• Within two (2) years of employment, incumbent must obtain certification as a Research Coordinator through the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA).
• If applicable, valid RN license from the State of West Virginia.

West Virginia University is a place of purpose and community. We take pride in our profound impact on the state of West Virginia and are committed to the personal and professional growth of our employees.

From the groundbreaking R1 research at our flagship campus in Morgantown to the career-oriented programs at WVU Potomac State in Keyser, and the technology-intensive programs at WVU Tech in Beckley, the contributions of WVU employees resonate across the state, touching lives and shaping futures.

At WVU, you will discover a supportive community that champions work-life balance and fosters a collaborative atmosphere. Our core values - service, curiosity, respect, accountability and appreciation - unite us as Mountaineers.

Join us at West Virginia University, where your work will make a lasting impact. To learn more about WVU, visit wvu.edu.

West Virginia University is an Equal Opportunity Employer. We invite all qualified applicants regardless of race, color, religion, sex, national origin, age, disability, genetic information, or Veteran status.