Are you an experienced Clinical Research Associate looking to join a dynamic and growing clinical research organisation?
We are seeking a CRA II to manage investigative sites across Germany, ensuring clinical trials are conducted in accordance with study protocols, ICH-GCP, and applicable regulatory requirements.
Key Responsibilities
Conduct site qualification, initiation, monitoring, and close-out visits.
Ensure patient safety, data integrity, and protocol compliance.
Perform source data verification and review study documentation.
Manage site relationships and provide ongoing support to investigators and study staff.
Assist with ethics committee and regulatory submissions where required.
Monitor investigational product accountability and site performance.
Maintain Trial Master File (TMF) documentation and support query resolution.
Collaborate with cross-functional study teams to ensure successful trial delivery.
About You
Life Sciences degree or equivalent experience, plus recognised CRA training.
Minimum 4 years' clinical research experience.
Minimum 2 years' monitoring experience as a CRA.
Strong knowledge of ICH-GCP, clinical trial regulations, and site management.
Fluent in German with a good command of English.
Excellent communication, organisation, and problem-solving skills.
Ability to work independently and manage multiple priorities.
Valid driver's licence and willingness to travel up to 75%.
What We Offer
Home-based flexibility.
Opportunity to work on international clinical trials.
Collaborative and supportive team environment.
Competitive salary and benefits package.
Skills Required
- Minimum of four years' clinical research experience (e.g., Clinical Trial Associate, Study Coordinator) or equivalent.
- Life Science degree or equivalent experience and completion of a recognized CRA training program.
- Minimum of two years' monitoring and site management experience as Clinical Research Associate.
- Pulmonology and Oncology therapeutic expertise.
- Excellent understanding of clinical research processes, clinical trial systems, regulations and Good Clinical Practice (GCP).
- Excellent written and verbal communication, time management, organizational and problem-solving skills.
- Fluent in German (speaking and writing) and good comprehension of English.
- Ability to work successfully in a matrixed team environment and strong interpersonal skills.
- Dedication to quality in all work tasks and deliverables.
- Ability to prioritize and manage multiple tasks, including during travel and monitoring visits.
- Working knowledge of computer systems, applications, and operating systems.
- Ability to travel up to 75%.
- Possess a valid driver's license, as required.
What We Do
Linical is a global Contract Research Organization (CRO) that provides a full spectrum of drug development services, from early-phase research to large-scale, multinational clinical trials. Headquartered in Japan, the company supports pharmaceutical and biotech clients with services including clinical trial management, regulatory consulting, and pharmacovigilance. Linical is committed to high-quality, patient-centered research, leveraging its global network to help bring innovative new therapies to patients worldwide.
