(Senior) Clinical Research Associate (s)CRA - sponsor-dedicated

Location: Home Office, Germany

A formula for clinical innovation: Covance + LabCorp. With comprehensive drug development services and de-identified data from 70 million patients worldwide, our 60,000 employees advance life-changing medicines across a wide range of therapeutic areas.

We are actively looking for experienced CRAs or SCRAs to work directly with one of our key sponsors and advance the development of innovative, life-changing medications for oncological therapies.

What we have to offer: a strong international support network, flexible working solutions, a highly competitive compensation package, and the opportunity to raise your profile in the industry. If you are looking to broaden your therapeutic expertise whilst gaining exposure within a world-class pharmaceutical working environment, this is the perfect opportunity!

Your responsibilities will include:

• Full responsibility for all aspects of site management as described in the project plans
• Ensure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the study
• Protect study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data
• Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; prepare accurate and timely trip reports
• Review progress of projects and initiate appropriate actions to achieve target objectives
• Interact with internal work groups to evaluate needs, resources and timelines
• Act as contact for clinical trial suppliers and other vendors as assigned
• Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
• Assist with training, mentoring and development of new employees, e.g. co-monitoring

Education/Qualifications:

• Degree in a relevant field such as pharmacology, (veterinarian) medicine, oecotrophology etc. or an equivalent scientific or commercial Higher Vocational education (e.g. study nurse, study coordinator) plus additional training as CRA

Experience:

• Solid experience in clinical research in a variety of therapeutic areas including Oncology
• Previous monitoring experience in Germany including familiarity with applicable German regulations and authorities
• Working knowledge of Microsoft Word, Excel and PowerPoint
• Effective time management and organizational skills and a keen attention to detail
• Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders
• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)
• Business fluency in German - both spoken and written - as well as a good command of English are a must