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Responsibilities of Research Staff

Corporate Director

  • Plans, organizes and coordinates research activities at the Research Department within Mountain States 
  • Critically evaluates the institution's adherence to applicable federal regulations, state laws and accreditation standards, which govern human research
  • Manages department and research budgets, sets up billing procedures; develops payment plans
  • Reviews and develops research contracts (service agreements, CTA & CDA).  Coordinates contract and billing compliance within MSHA.  Coordinates research related activities between Legal, Central Billing Office, Finance and Accounting Departments
  • Collaborates with sponsoring agencies; served as liaison with the IRB, ETSU, FDA, drug companies and other research institutions.
  • Creates reports for VP/CMO of Washington County and SVP/CMO
  • Serves as initial contact for new and potential study proposals
  • Oversees research staff, assists with hiring, training and development of new employees
  • Promotes the continuous education for quality assurance in research.  Participates as appropriate, in training, education and development of individuals responsible for the oversight or conduct of human research at MSHA.  Conducts monthly education sessions.
  • Completes internal audits for open studies (Class A) and regulatory audits for Class B and C
  • Participates in monitoring visits with sponsors (Class A; partially Class B)
  • Conducts implementation meetings, research staff meeting
  • Serves as a liaison between different departments (service arrangement for research studies)
  • Assists in developing plans to meet requirements of new studies / protocols; prepares for external quality assurance and review
  • Develops Procedural Manual and Standard Operation Procedures
  • Actively participates in development of e-IRB and MSHA applications
  • Participates in study-specific activities including conducting study visits, collecting samples, distributing IP, performing ECG, administering study questionnaires (Class A)
  • Participates in IRB meetings as an active member
  • Reports study data, develops source documents, responds to queries

Research Assistant

  • Manages trial documentation and reports (Class A)
  • Maintains records of local and Central IRB submissions
  • Maintains SAE/AE submissions / logs
  • Assists other staff with daily activities
  • Maintains and tracks internal invoices 

 

 

Nonna Stepanov, Corporate Director of Research
423-431-5454

StepanovNV@msha.com



Nonna Stepanov, MD, CCRC. , received Master Degree in Medicine from Kyrgyzstan. She has 20 years of combined clinical and research experience in both industry-sponsored and federal trials as well as investigator-initiated trials. She oversees the day to day functions of the department. She joined department in June 2011.


 

Christy Duncan
Research Assistant
423-431-5647
DuncanCE@msha.com


 



Administrative Structure