Michaela Massing

Working as a CRA since 2016;

Working as a CRA II 2018-2021; 

sCRA I since 2021;

 See my detailed education and professional career in my CV and respective cover letter upon response. Documents in German available if needed. 

-Since 2021 sCRA I at IQVIA GmbH:

• Performing site initiation, monitoring and close-out visits in accordance 
  with contracted scope of work and GCP. 
  - Supporting development of project subject recruitment plan; working
  with sites to adapt, drive and track subject recruitment plan in line with
  project needs to enhance predictability. 
  - Provide monitoring visits and site management (on-site and remote) for 
  variety of protocols, sites and therapeutic areas.  
  - Administer protocol and related study training to assigned sites and  
  establish regular lines of communication with sites to manage ongoing  
  project expectations and issues.  
  - Site contact per guidance and potential issue management to maintain  
  site performance and metrics stability, such as  
  Patient Retention and Adjudication; 
  Support in IMP shipments, Data Metrics, SAE reporting, DBLs; 
  Offsite support through ongoing support in between monitoring
  events to address site issues, metrics, reviewing clinical data incl.
  protocol deviations. 
  - Evaluate the quality and integrity of study site practices related to the  
  proper conduct of the protocol and adherence to applicable regulations.  
  Escalate quality issues as appropriate. 

I started working as a CRA in 2016 and during these years I have gained broad knowledge of the Clinical Research industry, procedures and various responsibilities expected from this role. Since 2021 and in my current position, I am working as a Senior Clinical Research Associate. Please consider my experience and qualifications: 

• Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
• Gain experience in study procedures by working with experienced clinical staff.
• Perform site initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.
• Administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, data query generation and resolution.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. 

2013 – 2017 
Studies in Nutritional Science with focus on Food Quality  
University of Vienna, Austria  
Title of qualification: Master of Science (MSc) 
Master’s Thesis: “Changes in bone metabolism in Morbidly Obese Patients
after Bariatric Omega-Loop Gastric Bypass Surgery: Influence of Vitamin D
and Calcium”

2008 – 2013 
Studies in Nutritional Science  
University of Vienna, Austria 
Title of qualification: Bachelor of Natural Science (BSc)

2003 – 2007 
Bundesoberstufenrealgymnasium Hartberg 
Academic High School 
Title of qualification: Matura