Elisa Schlunke

In-house site management of sites in Germany, Austria and Switzerland including qualification, initiation, monitoring and termination preparation, pre-Initiation document collection, Database Lock support, issue resolution, contract-amendment-development, ensuring timely and high quality data entry compliance from site, patient enrollment management

Trial Master File review; Study data entry via SAS 9.2; Data Validation; GCP Training and receipt of GCP certificate

Accompanying and supporting of monitoring visits; monitoring visit preparation; audit preparation; follow-up of site specific problems concerning invoices; obtaining of study documents; issue resolution according to quality checks performed from Central File; labeling, tracking and filing of study documents according to the Central File Maintenance Plan; creating File Notes; work according to PAREXEL internal SOPs

Study data entry via SAS 9.2

Accompanying an interim monitoring visit; writing a monitoring report; creating test patients in SAS 9.2 on the basis of the Data Validation Plan and the annotated CRF; work according to ICRC-Weyer internal SOPs

Topic of Bachelor Thesis: “Inclusion/Exclusion criteria in Phase I: Obstacles in recruitment of healthy volunteers”