freiberufler Clinical Trial Administrator auf freelance.de

Clinical Trial Administrator

offline
  • auf Anfrage
  • 90489 Nürnberg
  • Nähe des Wohnortes
  • gu  |  en  |  hi
  • 15.10.2020

Kurzvorstellung

Ich habe 8 Jahre Erfahrung in der klinischen Forschungsabteilung bei Pfizer India Ltd und der Morphosys AG Deutschland. vier jahr als CTA und zwei Jahr als CRA. Ich suche derzeit einen Teilzeitjob, d. H. CTA oder CRA Remote ( Home office).

Qualifikationen

  • Klinische Studie

Projekt‐ & Berufserfahrung

Clinical Trial Admistrator
Morphosys AG munich Germay, Munich
3/2015 – 2/2017 (2 Jahre)
Clinical Research
Tätigkeitszeitraum

3/2015 – 2/2017

Tätigkeitsbeschreibung

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.

Eingesetzte Qualifikationen

Klinische Monitor (CRA)

Clinical Research Associate
Pfizer, Mumbai
1/2011 – 8/2012 (1 Jahr, 8 Monate)
Clinical Research
Tätigkeitszeitraum

1/2011 – 8/2012

Tätigkeitsbeschreibung

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.

Eingesetzte Qualifikationen

Klinische Monitor (CRA)

clinical trial Specialist
Pfizer, Mumbai
3/2008 – 12/2010 (2 Jahre, 10 Monate)
Clinical Research
Tätigkeitszeitraum

3/2008 – 12/2010

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Klinische Studie

Ausbildung

Post Graduation Diploma in Clinical Research
Ausbildung
2009
Indien

Weitere Kenntnisse

Diploma in Clinical Research
Masters in Bio-informatics
Bachelors in Microbiology

Persönliche Daten

Sprache
  • Englisch (Fließend)
  • Deutsch (Gut)
  • Gujarati (Muttersprache)
  • Hindi (Fließend)
Reisebereitschaft
Nähe des Wohnortes
Arbeitserlaubnis
  • Europäische Union
Home-Office
bevorzugt
Profilaufrufe
1258
Alter
38
Berufserfahrung
16 Jahre (seit 03/2008)

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