Senior CRA / CRA II - Solid Tumor Direct Monitoring

About the role

Syneos Health is recruiting a Senior CRA/CRA II for a biopharmaceutical client, working on direct monitoring of solid tumor trials. The role is remote and requires proven experience with traditional on-site monitoring, including full source data verification, investigational product accountability and strict adherence to ICH/GCP and regulatory requirements.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits (on-site or remotely), evaluating site performance and escalating serious issues
• Verify informed consent, protect subject confidentiality and assess factors affecting safety and data integrity
• Review source documents and medical records, verify CRF data accuracy and completeness, resolve queries and check compliance with electronic data capture
• Check investigational product inventory, dispensing and administration, and ensure proper labelling, import and return of IP
• Review the Investigator Site File, reconcile it with the Trial Master File and document site activities
• Support recruitment and retention, enter tracking data, prepare for audits and train or mentor junior CRAs
• Manage site-level activities, communicate with sites and attend investigator and sponsor meetings

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Strong background in oncology clinical trials across all phases, including early-phase, first-in-human, safety, PK/PD and dose-escalation studies
• Phase I oncology experience is essential
• Hands-on experience with solid tumor indications (melanoma, breast, ovarian, prostate, lung cancer); TLR pathway, PARP1 inhibitor or Werner helicase experience is desirable
• English and German, and ability to travel regularly up to 75%

Required skills

• Good computer skills and openness to new technologies
• Excellent communication, presentation and interpersonal skills
• Basic critical thinking skills