(Hybrid) Clinical Research Specialist - Clinical and Translational Science Institute (Southern West Virginia)

The Clinical and Translational Institute at West Virginia University is currently accepting applications for a (Hybrid) Clinical Research Specialist located in Southern West Virginia.

About the Opportunity

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 investigators within the National Institutes of Health (NIH) CARE for HealthTM initiative, which is a pilot to test the feasibility of a network to embed clinical research in primary care settings. Performs a variety of independent and collaborative duties involved in clinical trial coordination and implementation, organization, oversight, documentation, tracking, data abstraction and collection and compilation of clinical research data under the direction of the West Virginia Clinical & Translational Science Institute Center of Excellence (WV CTSI COE). The position will be located in Southern West Virginia and the incumbent will be required to travel to primary care facilities and work on-site at those facilities to complete specific duties and responsibilities.

This position provides program, as well as direct internal and external client support services. Responds to inquiries and resolves matters of moderate to high complexity. Responsibilities require theoretical and practical knowledge, judgement, resourcefulness and originality. Diverse guides and precedents are usually available to apply or adapt to the circumstances. Work effort has considerable impact on client services, program and project image with potential legal liabilities.

We strongly believe in work-life balance and keeping time for things we love outside our work. WVU offers generous benefits, including:

• 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 benefit
• 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

• Protocol Compliance: Facilitates compliance with the requirements of the research protocol and good clinical research practice while remaining cognizant of the needs of diverse 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 diverse 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.
• Professional Development: Takes responsibility for identifying his or her ongoing professional development needs and seeks resources and opportunities to meet those needs, such as through membership in nursing, disease specialized (i.e. oncology nursing society), or research organizations.

• Bachelor's degree from an allied health discipline, or related medical field and/or RN degree
• A minimum of five (5) years of experience in the following:
  
  
  
  • Working in a clinical setting and/or experience working in clinical 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

• 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.
  
  
  
  
• Skilled at being aware of others' reactions and understanding why they react as they do.
• Skilled at communicating effectively in writing as appropriate for the needs of the audience.
• ]Skilled at using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approached to problems.
• Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Position requires excellent customer service skills and the ability to communicate effectively with patients and families; pharmaceutical company personnel; regulatory and monitoring agency personnel; and, internal staff members. Communicates with physicians, patients, students and employees of WVU, WVU Hospitals, MBRCC and UHA.
• Ability to develop constructive and cooperative working relationships with others and maintain them over time.
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
• Ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
• Ability to analyze information and evaluate results to choose the best solution, solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
• Ability to develop specific goals and plans, to prioritize, organize and accomplish tasks independently and through others.

Preferred Qualifications

• At least two (2) years of experience in critical care or specialized nursing unit

• 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
• Valid driver's license
• This position may require Medical Monitoring, including periodic health monitoring and/or training.

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.