Experienced Clinical Research Associate (F/M/N)
- Job Identification 299604
- Job Category Consulting
- Posting Date 06/20/2025, 05:41 PM
- Role Individual Contributor
- Job Type Regular Employee
- Does this position require a security clearance? No
- Years 3 to 5+ years
- Additional Info Visa / work permit sponsorship is not available for this position
- Applicants are required to read, write, and speak the following languages English, German
Job Description
J oin Oracle Life Sciences, a global leader in cloud technology, pharmaceutical research, and consulting trusted by professionals worldwide.
We are dedicated to advancing clinical development and improving patient outcomes through innovative solutions and real-world evidence.
With a focus on groundbreaking developments in Oncology and Rare Disease, alongside the integration of technology into medicine, there's never been a more exciting time to work in Life Sciences.
If you're seeking to expand your expertise and make a difference, join us and empower our clients and patients globally.
What you will do
As a Clinical Research Associate, you will play a vital part in supporting the Project Team throughout all stages of the study cycle in Germany. You'll closely collaborate with an international team based in the US and Europe.
Ideal Location: Munich.
This position requires minimal travel around 3 visits per month and focuses on Real-World Evidence studies (observational, non-interventional, post-marketing studies).
Responsibilities
Conduct site initiation, routine monitoring (phone/video calls, onsite visits), and close-out visits in accordance with study protocols, SOPs, and applicable regulations. Most of visits are conducted remotely.
Participate in site feasibility assessments and selection, including evaluating site capabilities and resources.
Preparation and submission of regulatory documents, including EC/IRB approvals and regulatory authority submissions as required.
Monitor site activities, including source document review/verification, patient enrollment, and adherence to study procedures and timelines.
Communicate effectively with site staff and investigators to address queries, provide training, and ensure study progress.
Manage contract execution and oversee the processing of site payments.
Maintain study (TMF) and site files (ISF) in accordance with regulatory requirements and company standards.
Participate in regular study team meetings and to provide reporting to the Project Team on study progress in Germany.
Ensure timely documentation of all study-related activities, including monitoring reports, correspondence, and maintenance of site trackers.
Contribute to developing and implementing process improvements to enhance study efficiency and quality.
Required Experience
Master’s degree in a scientific or healthcare-related field (Biology, Biochemical, Biotechnology, etc).
Minimum of 2+ years’ experience as a CRA working in CRO environment in Germany or Austria.
Understanding of regulatory requirements in Germany and experience in preparing regulatory submissions.
Strong self-organizational and communication skills.
Attention to detail and ability to work independently.
Ability to work collaboratively within a dynamic international team.
Fluent in written and verbal English and German both C1 level as a minimum.
We expressly encourage disabled candidates to apply for this position. Please therefore Feel free to voluntarily inform us in your application about any severe disability (degree of disability of at least 50%) or any equal status (degree of disability of at least 30% together with official decision on equality) in accordance with the German SGB IX.
Qualifications
Career Level - IC2
About Us
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