Marion Wendt

I completed additional training as a Clinical Research Associate in 1993 and the gained hands-on experience with a CRO and sponsor.
Since June 1997 I work as a freelance Senior Clinical Research Associate.

Through my involvement in several multicentre and multinational pharmaceutical studies (phases I-IV) as well as post–marketing studies within the therapeutic areas AIDS, Allergology, Cardiology, Dermatology, Diabetology, Endocrinology, Gastroenterology, Gynaecology, Hyperhidrosis, Immunology, Infectious diseases, Neurology, Nutrition, Obesity, Oncology, Ophthalmology, Orthopedy, Pain, Pneumonology, Psychiatry, Reproduction and Transplantation I am familiar with independent work “around clinical trials”.
Clinical trials of medical devices are also part of my experience.

I have fluent English and I am used to being flexible at home country and abroad. Working inhouse at sponsor is also a welcome assignment.

For further and detailed information about me please contact me directly. I will gladly provide you with further documents.

 I offer you the following activities:

• Budget planning and tracking
• Review protocol versus CRF as well as CRF creation
• Creation of patient information and informed consent
• Creation of study-specific documents
• Investigator recruitment
• Selection of trial sites
• Site qualification visits
• Support in ethics submission
• Notification of investigational sites to the competent authorities
• Conduct site initiations
• Monitoring (on-site and remote)
• Co-Monitoring and QC Co-Monitoring
• Coaching as well as mentoring of trial sites and CRAs
• Site closure visits
• Project Management
• Query resolution
• Trial Master File review at sponsor
• Organizing and realisation of investigator meetings
• Preparation of audits/inspections as well as participation and follow-up

 … and much more.

I conduct my activities according to the applicable regulations and recommendations (such as AMG, GCP Regulation, ICH GCP, MPG and ISO 14155) as well as the SOP`s of my clients.

Please contact me at cra@marionwendt.de or click contact,so that together we can discuss and plan your personal needs.

Responsible for the operation of this website

Marion Wendt
Senior CRA
Fichtenweg 22 a
46446 Emmerich am Rhein, Germany
Phone +49 (0) 2822 977417
Fax +49 (0) 2822 977418
E-Mail cra@marionwendt.de

VAT Reg No

DE187743741

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Firmazwei GmbH

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PRIVACY NOTICE

Responsible in the sense of the data protection laws, in particular the EU General Data Protection Regulation (GDPR), is: Marion Wendt, Fichtenweg 22a in 46446 Emmerich am Rhein, Germany.

General

Your data is collected when you provide it to us, for example by entering information in the contact form.
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We process your personal data only in accordance with applicable data protection law. The following information explains the nature, scope and purpose of the collection and processing of personal data. This privacy notice applies only to our website.

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• IP address
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They are processed in particular for the following purposes:

• Ensuring a hassle-free connection of the website
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There is no merge of this data with other data sources. We do not use your information to draw conclusions about your person.

The processing is carried out in accordance with Art. 6 para. 1 lit. f GDPR based on our legitimate interest in improving the stability and functionality of our website.

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If you use the contact form, we process your name, email address and message in order to identify and respond to your request. The information is forwarded to us by email through the hosting environment. The message is not stored in a dedicated website database. Where technically necessary, the hosting and email service providers used by us may process the data on our behalf.
The data entered in the contact form is processed on the basis of a legitimate interest (Article 6(1)(f) GDPR), as the contact form enables you to contact us easily. Your information is processed to handle your request and any follow-up questions.
If you contact us to request an offer, the data entered in the contact form is processed in order to take steps at your request prior to entering into a contract (Article 6(1)(b) GDPR).
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The provision of your personal data is voluntary. However, we can only process your request if you provide us with your name, email address and the reason for your request.

Technically Necessary Session When Submitting the Form

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We indicate that the data transmission in the internet (e.g. in the case of communication by e-mail) can have security gaps. A complete protection of the data from access by third parties is not possible. This applies in particular if you contact us by e-mail on your own initiative. Here, yourself are responsible for taking appropriate measures to transmit your data securely and to protect against access by unauthorized third parties.

Your Rights

You can exercise the following rights at any time under the contact details provided:

• Information about your stored data and their processing (Art. 15 GDPR)
• Correction of incorrect personal data (Art. 16 GDPR)
• Deletion of your stored data (Art. 17 GDPR)
• Limitation of data processing, if we are not yet allowed to delete your data due to legal obligations (Art. 18 GDPR)
• Objection to the processing of your data with us (Art. 21 GDPR) and data portability, provided that you have consented to the data processing or have concluded a contract with us (Art. 20 GDPR)

If you have given us your consent, you can revoke it at any time with effect for the future. For this purpose and for further questions on the subject of personal data, you can contact us at any time using the contact details provided in the imprint.
You also have the right to lodge a complaint with a data protection supervisory authority. The supervisory authority responsible for us is the State Commissioner for Data Protection and Freedom of Information of North Rhine-Westphalia, Kavalleriestraße 2–4, 40213 Düsseldorf, Germany, www.ldi.nrw.de.

Inclusion and Validity of the Privacy Notice

This privacy notice describes the processing of personal data when you use this website. It applies only to the content of our website. The linked external content is governed by other privacy and data security rules. The respective website's imprint identifies the party responsible for that content.
Due to the further development of our website or the implementation of new technologies, it may be necessary to change this privacy notice. We reserve the right to amend this privacy notice to comply with current legal requirements or to reflect changes to our services, for example when introducing new services. The current version applies to your next visit.

Last updated: October 2026