Clinical research associate II

Job title : Clinical research associate II
Location : Germany
Job type : Permanent
Salary : Up to £37500.00 per annum
Contact name : Brook Bridges
Contact email : brook.bridges@seclifesciences.com
Clinical research associate II
This company is a full-service CRO, who have been providing full oncology clinical trial services in the US and Europe for over three decades. They have designed and managed more than 250 early and late-phase oncology trials to date.
What you'll do
* You will assist in the day to day running of projects assigned acting as the routine liaison between study site and the project team for study related issues, making sure to provide ongoing updates and support to project management.
* You'll ensure protection of subjects, subjects' rights and the integrity of data through monitoring of adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures and protocol compliance
*As part of your daily routine you'll conduct pre-qualification, initiation, routine monitoring and close-out visits in accordance with the relevant SOPs and assist with regulatory and study start-up activities including contract and budget negotiations, as required
* It will be your responsibility to oversee junior members of the team and provide support.
What you'll bring to the team
Your qualifications
* You will have at minimum, Bachelor's degree (BSc, BA, or RN equivalent) in biological or science-related field or equivalent experience Prior Experience:
*You'll have Strong experience as a Clinical Research Associate accompanied by a record in managing clinical trial sites and Experience in monitoring oncology early phase studies.

Skills and Competencies to be demonstrated
* The successful candidate will have a thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements
* You will have good organizational skills and interpersonal skills
* You'll be knowledgeable in the identification, anticipation, and reporting to appropriate management problems relating to study conduct and effective in developing solutions to those problems
* You will have a strong knowledge of the drug development process
* You will have proficient knowledge of Outlook, Word, and Excel
Additional Requirements:
* Valid Driver's License and Passport is preferable
* Fluent in English and Dutch language is preferable.



What are your benefits?
You will benefit from the company's competitive compensation and benefits package which includes;
*Private medical insurance
*Life assurance
*Sick pay
*Income protection insurance
*Pension scheme
*Flexible work schedules
*Supportive culture that puts people first

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