Responsibilities
Monitor oncology clinical trial sites to ensure compliance with study protocols, SOPs, ICH-GCP, and applicable regulatory requirements.
Conduct site initiation visits, routine monitoring, and close-out visits, to verify data accuracy, patient safety and protocol compliance
Ensure proper documentation of issues and findings in the monitoring reports and follow-up letters.
Verify informed consent processes and review source documents to maintain data integrity and ensure patient safety.
Maintaining regular contact with site staff and investigators, liaise with internal teams to resolve queries and address protocol deviations or adverse events.
Train site staff on protocol and study-related procedures, ensuring proper documentation.
Report protocol deviations and initiate CAPA plans as needed.
Reconcile AEs and SAEs with source data and EDC entries.
Regularly review EDC data entries and follow up on query resolution.
Preparing and collecting essential study documents (e.g., FDA Form 1572, GCP certificates, Medical Licenses, Financial Disclosure Forms etc.)
Your Expertise
At least 3-5 years of previous experience in complex oncology clinical trials as a (Sr) CRA
Attention to detail with strong understanding of ICH GCP and local regulations
Proficient in electronic data capture (EDC) systems and TMF
Excellent communication and interpersonal skills, including the ability to resolve conflicts and find pragmatic solutions without breaking a sweat.
Adaptability & mindset - thrives in a fast-paced environment, adaptable to change, and capable of handling complex situations
Willing to travel to clinical sites in US as required
Why Eisbach
High‑impact seat: your monitoring ensure that trial data is clean, compliant, and ready to bring first-in-class oncology therapies to patients faster.
Flat hierarchy: direct access to decision makers means immediate support when resolving site issues or protocol deviations.
Agile cadence: clear priorities, instant feedback loops, biotech level momentum.