Clinical Research Quality & Regulatory Specialist - Rockefeller Neuroscience Institute

The Rockefeller Neuroscience Institute at West Virginia University is currently accepting applications for a Clinical Research Quality & Regulatory Specialist.

Rockefeller Neuroscience Institute

The WVU Rockefeller Neuroscience Institute (RNI) is a comprehensive multidisciplinary patient care, education, and research institute providing neurological and mental healthcare through more than 300,000 visits annually. The 300+ physicians and scientists of the RNI improve lives by pioneering advances in neuroscience, brain health, and therapeutics. The RNI team uses the latest technologies with academic, government, and industry partners to make tangible progress to combat public health challenges ranging from addiction to Alzheimer's disease.

The RNI's flagship facilities are located on the WVU Health Sciences campus in Morgantown, with more than 2,200 dedicated team members across seven departments, patient care units, and research laboratories. For more information, visit WVUMedicine.org/RNI.

About the Opportunity

Responsible for regulatory management of all protocols ensuring compliance with IRB policies and applicable regulations. 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 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

• Planning and Developing:
  • Function as a project quality manager liaising with the other functional groups (data, imaging, etc.) In collaboration with the Director of operations manages all aspects of clinical research quality control from project proposal, Institutional (IRB) approval, study conduct, data analysis and close out.
  • Develops research protocols, data management and trial management plans.
  • Develops Standard Operation Procedures for Research personnel
• Day to Day Activities:
  • Possess a sound and in-depth understanding of each protocol and provides administrative, quality and regulatory management ensuring compliance with IRB, GCP guidelines and code of federal regulations Responsible for regulatory management of all protocols ensuring compliance with IRB policies and applicable regulations
  • Prepares protocols and ongoing amendments for initial IRB submission including preparation of IRB Protocol Statement, Abstract, Consent and Assent Forms and Discussion.
  • Prepares and maintains submissions to regulatory bodies through the study life time E.g.: IND and IDE preparation, submission and maintenance)-
  • Prepares reports and functions as a liaison between Pl, IRB, sponsor, research team, and participants
  • Manages multiple projects/protocols concurrently in a dynamic environment.
  • Prepares, monitors, validates, and maintains all research documentations
  • Screens, enroll, and schedules research subjects to ensure compliance to research protocols
  • Assist with all aspects of data and source documentation, adverse experience reporting and maintenance of complete regulatory files.
  • Assist in the implementation, system administration and maintenance of patient databases including but not limited to the collection, analysis, and reporting of patient outcomes data.
  • Performs education training related to RNI research activities. Assist in support, training and onboarding of new research staff. Participates in writing of reports and other documentation of project status and project results Arranges and attends meetings, seminars, symposia and other events related to project efforts Work regularly with EPIC systems analysts and third party software developers to maintain the vendor interface, and to communicate and resolve issues.

• Bachelor's degree in a health related field
• A minimum of two (2) years of combined experience in the following:
  • Program Coordination
  • Clinical experience
• 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

• Maintains skills in, or knowledge of, internal funding mechanisms such as pilot grants
• Excellent English language oral and written skills
• Strong organizational skills
• Demonstrated ability to read and interpret documents
• Demonstrated ability to present information and respond to questions from groups or individuals
• Demonstrated ability to create and produce clear, concise paper and electronic documents
• Demonstrated ability to work in a multidisciplinary team environment and to coordinate participation of team members from various backgrounds
• Demonstrated project management experience preferred with exceptional organizational and time management skills
• Group facilitation, mediation and conflict resolution skills
• Skill in organizing resources and establishing priorities.

Preferred Qualifications

• A minimum of five (5) years of clinical experience preferred.

Obtain certification as a Research Professional through the Society of Clinical Research Associates (SoCRA) OR the Association of Clinical Research Professionals (ACRP) with three years of hire date.

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.