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Senior Clinical Research Associate - Finland

Eingestellt von Aerotek

Gesuchte Skills: Client, Consultant, Ip

Projektbeschreibung

My Client, A leader in it's field, is looking for a Senior Clinical Research Associate to work for them for a minimum of 12 months. They require a consultant 5 days per week and can be based in either their Helsinki or Tampere offices.

The successful candidate will have the following experience and responsibilities:

Ensuring that all sponsor related duties and responsibilities are met in accordance with guidelines and legislation.

- Taking part in the protocol writing- mainly operational parts and QC check
- Compiling independently various study documentation ie informed consent forms, CRFs, study product accountability forms, Investigator Site Files and Trial Master Files
- Compiling clinical trial applications. Coordinating and compiling documents to ethics committees and regulatory authorities
- Taking part in investigator/site selection and conducting pre-study visits
- Ensuring that sites have all protocol related supplies (in addition to IP) to start the executing study initiation and monitoring visits
- Ensuring that the study is conducted according to effective legislation, GCP-guidelines and study protocol
- Sharing Real Time information between study site and my client
- Ensuring that the patient selection is appropriate
- Following-up the subject recruitment regularly
- Source data verification
- Following the Serious Adverse Event reporting
- Verifying that the study data is delivered to data management within agreed timelines
- Preparing monitoring report within agreed timelines
- Following the implementation of the study budget
- Checking the study product accountability
- Ensuring that there are no delays in study data transfer to data management
- Ensuring TMF completeness and proper archiving of study documentation
- Conducting a study close-out visit
- Submitting the end of study notifications to EC and RA
- Other responsibilities appointed by the upper management

If you are interested and would like to discuss further then please send your up to date CV to Phil Rose on (see below) or call. Please note, you must be able to speak fluently in English and Finnish to be able to do this role.

Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice . By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.

Projektdetails

  • Einsatzort:

    Tampere, Finnland

  • Projektbeginn:

    asap

  • Projektdauer:

    12 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Aerotek