- Qualification as Clinical research associate at Pharmaakademie in Leipzig - practical experience in the field of clinical trials - Indikation Diabetes, cancer and haematologie, aplastic anemia, MS and sepsis
- Qualification GCP - 2016
- management with navision - 2017
- projektmanagement and efficient cost calculation in clinicals trial - 2015
- risk based monitoring - 2015
Clinical Trial Manager (CTM)
Since October 2014
Management anf monitoring task including
- Verifying and ensuring that all assigned project team members are trained.
- Start up, feasibility, close out, end of study, archiving TMF
- Contributing to study documents development.
- Developing/review and revise project plans.
- Safeguarding quality of study conduct.
- Vendor selection and auditing
- Supporting/ submission Regulatory Affairs to EC/IRB submission process Germany, Switzerland, France, Italy and NL.
- Reviewing and verifying that all required documents
- Ensuring the set- up and maintenance of the clinical trial master files.
- Responsible for project costs.Preparing study budget forecast.Monitoring and co monitoring of study site
- Oversight and reviewing monitoring for outsource monitors
- Set up priorities
CRA - project management position
Since March 2014
CTM and Project managment, CRA and application to ethics committee, Trainee in clinical research, project management for three month from July to October 2014 looking CRA/project management position for Phase I, II, III or NIS Why? It is perfect for me, my interests and my personality.
Postdoc cancer research-epigenetics
January 2010 --- January 2012
Post Doc—Cancerogenesis/Department of Environmental Medicine Determine role of nickel in lung carinogenesis following long- and short-term nickel treatment. PCR, qPCR, run on assay, ChIP with H3K4me3, H3K9me2, H3K27me3, CTCF, IP experiments protein isolation, Westernblot, phosphatase assay, Mass spectrometry, presentation of results. Accomplishments: • Performed molecular biological design of endogenous protein tagging in human cell lines • Contributor: Tchou-Wong K.M, Kiok K., Tang Z., Kluz T., Arita A., Smith P.R., Brown S., Costa M. (2011): Effects of Nickel Treatment on H3K4 Trimethylation and Gene expression. PLoS ONE 6(3):1-10. • Contributor: Kathrin Kiok, Hong Sun, Hailey Clancy, Sutapa Bose, Thomas Kluz, Fen Wu and Max Costa (2011): Liprin-_4 is required for nickel induced Receptor Protein Tyrosine Phosphatase Leukocyte antigen-related receptor F (RPTP-LAR) activity. PLoS ONE 6(8):1-9. • Contributor: Wu F, Sun H, Kluz T, Clancy HA, Kiok K, Costa M. (2012): Epigallocatechin-3-gallate (EGCG) protects against chromate-induced toxicity in vitro. Toxicol Appl Pharmacol. 15; 258(2):166-75.
May 2006 --- September 2009
Served as part of a consortium to receive plant material after cold, heat or UV stress and perform analysis regarding changes after abiotic stress by qPCR, histone- and DNA methylation, and heritable stress-induced loss of gene silencing. Accomplishments: • Contributor: Mladek C., Popova O., Kiok K., Berlinger M., Aufsatz W., Jonak C., Hauser M.T. and Luschnig C. (2010): Heritable, stress induced loss of gene silencing in Arabidopsis isantagonized by seed aging. Plant Molecularbiology. Equal contribution. • Contributor: Aufsatz W, Stoiber T, Rakic B, Naumann K. (2007): Arabidopsis histone deacetylase 6: a green link to RNA silencing. Oncogene, 26(37), 5477-88.
PhD and Biochemistry Student
October 1992 --- December 2005
A public research-oriented university. Ph.D. Student Utilized recent studies with the Arabidopsis model system to perform comparable analysis of Su(var)3-9 genes in plants. Established Arabidopsis thaliana as new experimental system by isolating the first SET domain-encoding gene from rice and the first Su(var)3-9 homologous genes in Arabidopsis. Successfully applied new strategies in cloning the Su(var)3-9 homologous genes of Arabidopsis. Conducted plant epigenetic research experiments. Taught undergraduate students in analysis of the histone methyltransferase SUVH2 in vivo.
Analytical thinkingEfficiencyIndependenceInterest in knowledgeProactivityProblem solvingResult Oriented
Diabetes Phase I R&DClinical monitoringClinical operationsBudget ManagementBudget NegotiationBudget ProcessBudgetingBusiness ProcessBusiness Process ImprovementCancer ResearchClinical trial managementCRFCROEnglishEnglishForecastingGermanGood Clinical Practice (GCP)Informed Consent DocumentsInformed Consent ProcessInternational Project ManagementMicrosoft OfficeMicrosoft PowerpointMicrosoft ExcelMicrosoft WordMonitoring Study ProgressOncology Clinical ResearchPhase IIPhase IIIPhase IVPrinciples and ethics of clinical researchProblem-solving methods and troubleshootingProject ManagementRegulatory affairsRegulatory ComplianceRegulatory RequirementsRegulatory submissionsRisk Management
Skills and Expertise
Build and manage the Trial Master File (TMF) Interact with nurses Interact with physicians Monitor a clinical studyApprove monitoring reportsApprove patient informationApprove queriesArchive documentationArchive study documentsAssemble regulatory applicationsAssess site feasibilityAttend investigator meetingBuild trial master file (TMF)budgeting of R&D activitiesCalculate process efficiencyCalculate timelines for conducting and completing the trialCalculate trial timelinesCollaborate with principal investigatorCollaborate with project teamCommunicate with investigatorCommunicate with sponsorConduct close-out visitsConfirm protocol complianceCoordinate ethics committeecoordinating research projectsGenerate regulatory submissions
Qualification project management in Project Management from Lovania Akademie Leipzig in 2014
ICH-GCP in Clinical Research Associate – CRA (10/2012 – 01/2013) from Pharmaakademie Tom Chilcott in 2013
Ph.D in Genetics/Molecular Biology from Martin Luther University in 1998
Dr rer nat in Molecularbiology, Epigenetics from Martin Luther University Halle Saale in 0
Training and Certification
Navision in 2017 Training
GCP in 2016 Certification