Clinical Research Quality & Regulatory Specialist - Rockefeller Neuroscience Institute

Job Description
- Clinical Research Quality & Regulatory Specialist
- Rockefeller Neuroscience Institute (30457)

Clinical Research Quality & Regulatory Specialist
- Rockefeller Neuroscience Institute 30457

Description

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

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 .

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:

• 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)
• 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

• 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…