freiberufler Clinical Trial Specialist auf freelance.de

Clinical Trial Specialist

zuletzt online vor 9 Tagen
  • auf Anfrage
  • 69124 Heidelberg
  • Weltweit
  • en  |  de
  • 18.09.2023

Kurzvorstellung

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TMF Management. CRA, Project Management etc.

Qualifikationen

  • GxP
  • Klinische Monitor (CRA)
  • TMF Management

Projekt‐ & Berufserfahrung

Clinical Research Specialist / CRA
Kundenname anonymisiert, Mannheim
8/2015 – 7/2018 (3 Jahre)
Clinical documentaton specialist TMF
Tätigkeitszeitraum

8/2015 – 7/2018

Tätigkeitsbeschreibung

Creating and maintaining the Trial Master File (TMF), inspections of the study documents for completeness, accuracy and compliance and SOPs and regulatory requirements. Compilation of the document packages for medication release for study centers, by Ensuring the completeness, correctness and that receipt, as well as carried out timely. Receipt of central and the country- specific study documents of clinical teams, countries and / or CROs. Collection and verification of the results of study documents for completeness, accuracy and compliance with
SOPs and regulatory requirements, support in obtaining the medication released. Familiar with IRB terminology, approvals, FDA regulations, and Clinical monitoring process in accordance with GCP/ ICH Guidelines SOPs and study
protocols. Following up with module inquiries and initiating solutions. Make sure that the center documents are updated as necessary and manage and maintenance Study documents. Reporting of document status and communicate issues /
problems to the clinical team (CSL / CRA),Tracking of documents and regular alignment with the documents, Care of the documents in auditor- and achievable state Gathering the Investigator Participation and preparation for regulatory
audits and QA as well as Inspection Readiness.
Therapeutic experience includes: Oncology , Neuroscience, Immunology, HCV phase I- Close out visit, Clinical Drug Trail Experience with eTMF.

Eingesetzte Qualifikationen

Klinische Monitor (CRA)

CRA
Kundenname anonymisiert, Mannheim
12/2012 – 6/2014 (1 Jahr, 7 Monate)
Life Sciences
Tätigkeitszeitraum

12/2012 – 6/2014

Tätigkeitsbeschreibung

Clinical Research Associate / Monitor Collected reviewed monitoring Reports Assists with safety reporting by exporting from Clinical Database for Administrative Reports, and maintain tracking document Track CRFs and communicate any discrepancies / queries with CRAs and site. Performed study start-up for sites by collecting valuable documents and updating start-up supplies, site visits to determine protocol, Edit, review and maintain team travel calendars to reflect changes and routinely post to client and team members. Familiar with IRB terminology, approvals, FDA regulations, and Clinical monitoring process in accordance with GCP/ICH Guidelines SOPs and study protocols. Following up with module inquiries and initiating solutions. Liaison between client databases (CPMS Remote Patient), helpdesk and team. Report and track Serious Adverse Event / AEs and Progress on Regulatory Document collection.
Therapeutic experience includes: Oncology, Neuroscience Phase I-II Clinical Drug Trail Experience.

Eingesetzte Qualifikationen

Klinische Monitor (CRA)

Ausbildung

Public Health
Doctorate (Yes)
2020
USA
Clinical research associate
Ausbildung
2014
Mannheim
Nano-biotechnology
Postgraduate (Yes)
2009
Kaiserslautern
Biochemistry
BSc. (Yes)
2001
Auslander / annerkannt

Über mich

I possess great experience in data management, experimental designs, biotech, data analysis and computer program. Matlab, imagej etc. used by researchers. In addition to this, I can carry out clinical safety precautions safely. As you can see from my enclosed resume, I am very skilled in Roles and Responsibilities of the Investigator; Roles and Responsibilities of the Institution; Regulatory Issues e.g. FDA Guidance regarding Clinical Trials, ICH Guideline for Good Clinical Investigators. Performing and coordinating external clinical studies; site selection, protocol development, and closeout, Preparing reports, and publications required for product launch. I possess great skills in maintaining contact with study investigators to make sure that studies are opportune, performing internal performance testing, which includes, stability, proficiency, product development, reviewing cases with investigators to determine discrepancies, Study documents and to ensure the inspection condition. Represent the Clinical Documentation Center (formerly Document Management) in Studies teams. Contribution to departmental development through training and mentoring, as well as data management, audit and inspections, clinical trials overview, GCP - documents and Registration Authorities.

In addition to my extensive experience, I am highly proficient in computer skills, including Microsoft word, Outlook, MS office, MS project, power point, and excel. I have the ability to learn new software systems My communication abilities are not in doubt as I can achieve effective communication both written and orally. I can therefore speak and write simply, clearly and succinctly in English, German. My experience and skills coupled with my qualification and commitment to duties will be valuable to your organisation. With 4 years' experience as a Document Specialist and CRA, I am adept in file management, reporting, and document control. Moreover, while my on-the-job experience has afforded me a well-rounded skill set, including first-rate multi-tasking and prioritisation skills. I am competent in all my areas of research and studies and deem myself highly competent and qualified for this position. I can work and deliver the required result under pressure.

Also, I possess a solid educational foundation and passion fore efficient and accurate document control I am extremely enthusiastic about your company focus on updating file system and would welcome the opportunity to contribute to your continued success.

Please review my attached resume for additional details regarding my expertise and career achievements. I will follow up to request an appointment to discuss how my experience and background meet your needs.

Below is my LinkedIn link for details;

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Weitere Kenntnisse

MS office, SAP MM, EDL, eTMF, CRA

Persönliche Daten

Sprache
  • Englisch (Muttersprache)
  • Deutsch (Fließend)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Profilaufrufe
1676
Alter
44
Berufserfahrung
11 Jahre und 3 Monate (seit 12/2012)
Projektleitung
5 Jahre

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