Job Overview :
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
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