Freelance Senior Clinical Research Associate and Quality Assessor/Auditor

freiberufler Freelance Senior Clinical Research Associate and Quality Assessor/Auditor auf freelance.de
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Europa
en  |  de
auf Anfrage
54470 Bernkastel-Kues
06.05.2016

Kurzvorstellung

Freelance SCRA with 20 years expierence in phases I-IV and medical device studies.

Ich biete

Forschung, Wissenschaft, Bildung
  • Klinische Monitor (CRA)
  • Klinische Studie
Management, Unternehmen, Strategie
  • Auditor

Projekt‐ & Berufserfahrung

Freelance Lead Senior Clinical Research Associate
Cmed/ Onxeo, all
3/2015 – 4/2016 (1 Jahr, 2 Monate)
Gesundheitswesen
Tätigkeitszeitraum

3/2015 – 4/2016

Tätigkeitsbeschreibung

• Attendance at project team meetings
• Liaison with clients and investigators to ensure efficient
• Co-ordination of Clinical Monitoring Team
• Team Management in 18 Countries
• Attendance at project team meetings

Eingesetzte Qualifikationen

Klinische Studie


Quality assessor
Cmed, all of Europe
3/2015 – offen (5 Jahre, 5 Monate)
Gesundheitswesen
Tätigkeitszeitraum

3/2015 – offen

Tätigkeitsbeschreibung

Conduct quality assessment visits with CRAs in Europe on various protocols.

Eingesetzte Qualifikationen

Klinische Studie


Freelance SCRA
Cmed/ Biothera, various locations
7/2014 – offen (6 Jahre, 1 Monat)
Gesundheitswesen
Tätigkeitszeitraum

7/2014 – offen

Tätigkeitsbeschreibung

• Central point of communication for all site related issues
• Conduct of monitoring and close-out visits, PhaseIII study was conducted to a variety of standards and regulations, including European GCP guidelines and FDA Standards.
• Production of comprehensive visit reports and status reports
• Site maintenance

Eingesetzte Qualifikationen

Klinische Monitor (CRA)


Freelance SCRA
Various, Germany,Austria, Switzerland
8/1994 – offen (26 Jahre)
Clinical Research
Tätigkeitszeitraum

8/1994 – offen

Tätigkeitsbeschreibung

Responsibilities:
• Preparation of EC submission
• Identification of potential investigators
• Central point of communication for all site related issues
• Conduct of pre-study; initiation; monitoring and close-out visits, Phase I- IV-studies were conducted to a variety of standards and regulations, including European GCP guidelines and FDA Standards.

Freelance Senior Clinical Research Associate
Clinical Operations Coordinator
Lead CRA
Medical Device Clinical trial specialist
Quality assessor
Auditor

• Production of comprehensive visit reports and status reports
• Site maintenance
• Attendance at project team meetings
• Liaison with clients and investigators to ensure efficient
• Co-ordination of Clinical Monitoring Team
• Team Management in 17 Countries
• Production of status reports
• Conduction of Joint visits
• Conduction of Pre-Audits
• Attendance at project team meetings
• Quality Assurance
• Attending Project Team Meetings
• Potential Query review
• Oversee CA, LEC and EC submissions
• Audits

Eingesetzte Qualifikationen

Klinische Monitor (CRA)


Zertifikate

2014 Audit basic course, 2016 GPV Auditor pharmacovigilance, 2016 GCLP Audits of bioanalytical laboratories, 2016 Communication strategies in the audit
März 2016

Ausbildung

Medical Assistant
(Ausbildung)
Jahr: 1982
Ort: Austin, Texas

Qualifikationen

Freelance Senior Clinical Research Associate
Clinical Operations Coordinator
Lead CRA
Medical Device Clinical trial specialist
Quality assessor
Auditor

Über mich

I have conducted Studies in the following indications. Anesthesiology, Cardiovascular, Endocrinology, Gastrointestinal, Genitourinary, Genetic, Hematology, Immunodeficiency, Musculoskeletal. Oncology and Medil devices. The Studies were conducted in Germany, Austria and Switzerland.

Persönliche Daten

Sprache
  • Englisch (Muttersprache)
  • Deutsch (Fließend)
Reisebereitschaft
Europa
Arbeitserlaubnis
  • Europäische Union
Home-Office
unbedingt
Profilaufrufe
961
Berufserfahrung
25 Jahre und 11 Monate (seit 08/1994)

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