I possess more than 10 years of progressive experience in the clinical research field. I started to work as Junior CRA at SRA (formerly Constella Group) and now I am working as Senior CRA at PPD. As the SCRA, my responsibilities include: conduct of pre-study visits, initiation visits, monitoring visits and close-out visits; collection and management of essential documents from the sites as well as site management to ensure proper adherence to protocol, source data verification, co-monitoring visits with junior CRAs. I have experience across a wide range of clinical indications/therapeutic areas (phases I to IV of clinical trials) and ability and experience to work with an electronic case report form (eCRF) namely Oracle Clinical Remote Data Capture , Medidata Rave and Inform. Experience in the following therapeutic areas: 1) Oncology (NSCLC, neoplasm of Liver, neoplasm of Oesophagus, neoplasm of female Breast, Prostate Cancer) 2) Nervous System/Sense Organs (Pain, Epilepsy and Multiple Sclerosis) 3) Endocrine-Metabolic (Diabetes Mellitus) 4) Respiratory (COPD, Asthma) 5) Circulatory 6) Allergy 7) Primary Hyperoxaluria 8) Dermatology (cSSTI and Acne Vulgaris) 9) Morbus Gaucher

• Site management, including the conduct of pre-study visit, initiation, monitoring visits and close out visits in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP), and Standard Operating Procedures (SOPs) • Collection of Essential Documents in compliance with the study specific Regulatory Document Plan • Preparation of Ethics Committee applications and notifications to local health authorities in Germany a) Initial submission and revision of documents according to EC requirements b) Submission of Substantial Amendments c) Notification to EC regarding non-substantial amendments d) Notification to EC regarding study end e) Notification to higher federal authorities according to § 67 of AMG • Preparation of project status reports • Liaison with investigational site staff, project team members, central laboratories, Investigational Medicinal Product distributors, and data management • Active participation in study team meetings • Regular training on ICH-GCP, national regulatory requirements, indications under investigation • Experience with eCRFs: PhaseForward, MediData, Oracle • Regulatory Authority Experience: a) Support of Regulatory Authority Managers by the study submission to regulatory authority / communication to PEI / BfArM to clarify some questions regarding submission process b) Participation in the 1-day-training “Basics of marketing authorisation of pharmaceuticals in Germany” • Participation in a six-month trainee Clinical Research Associate program • Co-monitoring visits with junior Clinical Research Associate

CRA trainee participated in a six-month trainee Clinical Research Associate programme. CRA trainee on phase IV Malignant neoplasm of female breast trial, on phase IV epilepsy trial, and on a phase IV pain trial. Performed the co-monitoring (pre-study visits, interim monitoring visits, close-out visits) with the experienced CRAs, performed drug accountability, archived of study documents, wrote monitoring visit reports in parallel to the responsible CRAs, compared and discussed reports with the mentor. Entered the data in CTMS. Supported the working group by the preparation of the computerised internal system of SOPs, templates, general processes of the conduct of clinical trials.

To work on project " Crystallographic structure of protein CK2" within international scientific group (Germany, Italy, Denmark, France). To hold of seminars. To perform laboratory tests with students.

To hold of seminars and to perform laboratory tests with students.

Chemistry teacher/Classroom management.

Biochemistry, Dr. rer. nat.

Doctoral Thesis Chemistry, Physical CHemistry, Electrochemistry

Chemistry, Physical CHemistry, Electrochemistry