CRA II/Sr CRA, Oncology Experience

🕒 2 days ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Perform site qualification, site initiation, interim monitoring, site management, and close-out visits, on-site or remotely • Ensure regulatory, ICH-GCP/GPP, and protocol compliance • Evaluate site and site staff performance, communicate serious issues, and develop action plans • Verify informed consent, subject/patient confidentiality, safety, clinical data integrity, protocol compliance, and pharmacovigilance issues • Assess site processes and conduct source document review of site documents and medical records • Verify clinical data entered in case report forms and drive query resolution to closure • Use hardware and software to support clinical study data review and capture • Verify compliance with electronic data capture requirements • Perform investigational product inventory, reconciliation, storage, dispensing, administration, and blinding reviews as applicable • Review Investigator Site Files, reconcile them with Trial Master Files, and ensure archiving compliance • Document monitoring activities through confirmation letters, follow-up letters, trip reports, communication logs, and other project documents • Support subject/patient recruitment, retention, and awareness strategies • Track observations, ongoing status, and action items to resolution • Manage site-level activities and communication to meet project objectives, deliverables, budgets, and timelines • Act as primary liaison with project site personnel or collaborate with a Central Monitoring Associate • Ensure assigned sites and project-specific site team members are trained and compliant • Prepare for and attend Investigator Meetings, sponsor meetings, clinical monitoring/project staff meetings, and training sessions • Support audit readiness and audit preparation/follow-up actions • Provide training or mentorship to junior CRAs and conduct training/sign-off visits when assigned • Perform clinical operations lead tasks under supervision when assigned

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Strong background in oncology clinical trials • Experience with early phase/first-in-human studies, safety, PK/PD, and dose-escalation designs • Hands-on experience supporting solid tumor indications such as melanoma, breast, ovarian, prostate, and lung cancer • Prior exposure to investigational products involving Toll-Like Receptor (TLR) pathways, PARP1 inhibitors, or Werner helicase protein is desirable but not required • Fluency in both English and German • Good computer skills and ability to embrace new technologies • Excellent communication, presentation and interpersonal skills • Basic level of critical thinking skills • Ability to manage required travel of up to 75% on a regular basis

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate

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