Location: Germany (Candidates must be based in Germany)
Position Type: Full-Time / Contract
Therapeutic Area: Oncology
Language Requirements: Fluent German and English
Position Overview
KlinEra Global Services is seeking an experienced Senior Clinical Research Associate (CRA) with a strong background in oncology clinical trials to support clinical trial monitoring activities across Germany. The successful candidate will ensure compliance with the clinical trial protocol, ICH-GCP guidelines, applicable EU regulations, and local regulatory requirements while maintaining high standards of patient safety, data integrity, and site quality.
Key Responsibilities
- Conduct site selection, site initiation, interim monitoring, and close-out visits for oncology clinical trials.
- Monitor clinical trial sites to ensure compliance with study protocols, ICH-GCP, applicable EU Clinical Trials Regulation, and relevant German requirements.
- Perform source data verification (SDV), source data review (SDR), and review of essential study documentation.
- Oversee patient recruitment, informed consent, eligibility verification, and protocol compliance.
- Review adverse events (AEs), serious adverse events (SAEs), and safety reporting documentation in collaboration with investigators and study teams.
- Identify, document, and follow up on protocol deviations, data discrepancies, and site compliance issues.
- Maintain accurate monitoring visit reports, follow-up letters, and trial documentation within the applicable timelines.
- Collaborate with investigators, site staff, Clinical Trial Managers, and cross-functional study teams.
- Support site readiness, inspection preparedness, and resolution of monitoring findings.
- Travel to clinical trial sites across Germany as required.
Required Qualifications and Experience
- Bachelor's degree or higher in Life Sciences, Pharmacy, Nursing, or a related discipline.
- Minimum 5 years of clinical research monitoring experience, preferably as a CRA.
- Proven experience monitoring oncology clinical trials.
- Strong knowledge of ICH-GCP, clinical trial regulations, and risk-based monitoring principles.
- Fluent in German and proficient in English, both written and spoken.
- Must currently reside in Germany and be eligible to work in Germany.
- Experience with EDC systems, electronic Trial Master File (eTMF) platforms, and clinical trial management systems (CTMS).
- Excellent communication, organizational, problem-solving, and site management skills.
- Ability to work independently and manage multiple clinical trial sites.
Preferred Qualifications
- Experience with Phase I to Phase III oncology studies.
- Familiarity with EU Clinical Trials Information System (CTIS) and applicable German ethics committee and regulatory processes.
- Experience with complex oncology protocols, including investigational medicinal products and safety oversight.
- Previous experience working with international CROs or pharmaceutical sponsors.
What We Offer
- Opportunity to contribute to oncology clinical trials with an international clinical research organization.
- Collaboration with experienced clinical operations and global study teams.
- Professional engagement in a dynamic, quality-focused clinical research environment.
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