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