Clinical Trial Administrator

3/2015 – 2/2017

Clinical Trial Administrator (with monitoring activities) Morphosys AG Germany.
 Supporting the preparation of clinical trial related documents
 Contribute to setting up and maintaining forms and documents relating to investigator Site Files and Trial Master File
 Provide and contribute to clinical trial information for tracking tools and updates, incl. invoice tracking
 Act as Filing and Archiving delegate for clinical trial specific documents
 Supporting the set up and maintenance, including filing of documents in the Trial Master File, clinical trial records and tracking systems including electronic documents in accordance with ICH-GCP and the company's SOPs
 Tracking and processing of invoices
 Arranging for document translations
 Checking documentation during and after clinical trial conduct according to company SOPs (incl. quality
 Setting up standardized regulatory document tracking spreadsheets per clinical trial
 Generate and maintain listings related to clinical trial activities in various databases (e.g. site listings, tracking patient visit status etc.)
 Distribute all outgoing site communications (letters, faxes, newsletters, etc.).
 Provide support to the clinical team for the set up and administration of clinical trials (advisory boards, investigator meetings)
 Booking travels for colleagues checks
Monitoring activities.
 Verification of subject safety and site activities in adherence to ICH guidelines.
 Monitoring conduct of clinical trials, especially enrollment, subject safety, site training and quality of data.
 To ensure complete and thorough study drug reconciliation.
 To ensure Adverse Events are reported appropriately, accurately and in a timely manner and follow-up activities are conducted as necessary.
 Review of Case Report Form, Informed Consent Documents and eCRF query resolution.
 Management of Investigator's site file and Pharmacy site file and to ensure communication requirements between site, sponsor and central Lab vendors.
 To Provide support and timely follow-up with site for regular clinical trial activities.
 Generated Monitoring visit report for the monitoring visit conducted.

Klinische Arbeiten

1/2011 – 8/2012

Monitored Phase II and III Trials in different therapeutic Area i.e. (Diabetes studies, oncology Studies, COPD study, Fibromyalgia and Pain study).
 Verified subject safety and site adherence to FDA and ICH regulations/ guidelines.
 Independently Conducted 18 Pre-Trial assessment visits, 10 site Initiation visits, 8 Closeout visits and regular monitoring visits.
 Monitored conduct of clinical trials, especially enrollment, subject safety, site training and quality of data.
 Ensured complete and thorough study drug reconciliation.
 Trained sites on the use and maintenance of IVRS, IWRS, Data entry.
 Trained site staff on the protocol, protocol amendments and sponsor processes
 Ensured Adverse Events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary.
 Reviewed Case Report Form Informed Consent Documents and query resolution.
 Managed site master file contents and work with sites to ensure
 Communication requirements between site and Institutional Review Board are adhered to. Provide support and timely follow-up for all audit and quality assurance activities.

Klinische Arbeiten

3/2008 – 12/2010

Trial Master File (TMF) maintenance in accordance with ICH-GCP and SOPs
 Study Start-Up Activity :
 Coordinated for application of export/import license of study drugs, lab kits, equipments, and specimen, if applicable.
 Responsibility for preparation, compilation, accuracy review of Investigator Initiation Package documents and obtaining approval(s) to ensure drug release in the defined timelines.
 Study Conduct Activity:
 Supported and coordinated for the clinical trial application for amendment and progress report to ethics committee and regulatory authority, and to obtain approval within required timeline.
 Ensured along with the CRA the reconciliation of Trial Master File and the Site Master File on a periodic basis.
 Responsible for revision of all the applicable documents as and when required in a timely manner (e.g. FDA 1572 form, financial disclosure form)
 Assisted in preparation of newsletters and other study-related documents. Assisted CRA for the responsibility of tracking, distribution and filing of clinical trial documents/information (e.g. paper CRFs, DCFs) with quality review for accuracy and completeness.
 Study Close-Out
 Ensured along with the CRA the reconciliation of Trial Master File
and the Site Master File. Supported Study manager and clinical research associate for final archive of study-related document

Klinische Forschung