Senior Clinical Research Associate

Over 20 years of experience as Clinical Research Associate in several therapeutic areas

Extensive expertise in the clinical phases I-IV

Profound knowledge in training and coaching of test center personnel to ensure quality standards

Broad insight in the entire study life cycle from selection and initiation to monitoring and close out

Clinical monitoring of current studies (phase 2-3)

Study preparation / Study Start up

Qualification & Initiation Visits

Submission processes (preparation of ethics submissions)

Supervision of studies

Drafting of study documents

Phase Ib-trial in patients with advanced melanoma, responsible for 2 German sites

Phase II-trial in patients with Head and Neck squamous cell carcinoma

Support sites in conduct of study, perform monitoring visits onsite and remotely, write reports, perform close out

Participate in Study Team Meetings

2 breast cancer studies Phase III

Conduct Site Initiation Visit, monitoring visits

Support Data Interim Analysis, write reports

Main POC for all study related questions and issues, train site personnel on study related topics and procedures, perform close-out visits

Submission of amended protocols and ICFs, Translation of local ICFs

Review monitoring visit, reports, oversee monitoring activities and database lock activities

Ensure timelines are kept, oversee study budget

Function as point of contact for local vendor issues

Support CRAs in issue management

Training of CRAs and sites on study matters, procedures and documents

Primary point of contact for PIs and site study staff

Preparation of a data interim analysis, maintenance and reconciliation of ISF and eTMF

Perform monitoring visits including drug accountability and SDV

Report writing for respective visits closing out sites in this trial

Preparing sites for study start and collecting regulatory documents site initiation and performing respective trainings, supporting sites in study conduct

Being part of a CRA team on a high recruiting site with need of special surveillance by CRAs due to high workload and high level of required support due to changing study team members

Offering trainings to new site personnel spread over all studies in progress for MSD

Supporting new employees at MSD in getting started within the company

Maintain the blind, primary point of contact for pharmacies

Drug accountability and perform corresponding SDV, eTMF reconciliation

Preparation for study start