Senior CRA/CRA II, Solid Tumor Monitoring

🔥 8 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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 • Evaluate site and site staff performance and provide recommendations for site-specific actions • Communicate and escalate serious issues to the project team and develop action plans • Verify informed consent, subject confidentiality, patient safety, clinical data integrity, and protocol compliance • Conduct source document review and verify clinical data in case report forms • Resolve queries remotely and on-site within agreed timelines • Use hardware and software for clinical study data review and capture • Verify site compliance with electronic data capture requirements • Perform investigational product inventory, reconciliation, storage, security, dispensing, and administration reviews • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities through letters, trip reports, communication logs, and project documents • Support subject/patient recruitment, retention, and awareness strategies • Track observations, site status, and action items to resolution • Manage site-level activities and communications to meet project objectives, deliverables, budgets, and timelines • Liaise with project site personnel and Central Monitoring Associates • Ensure assigned sites and project-specific site team members are trained and compliant • Attend investigator and sponsor meetings and participate in clinical monitoring/project staff meetings and training • Support audit readiness, audit preparation, and follow-up actions • Provide training and mentorship to junior CRAs and perform training/sign-off visits as 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 • Experience as CRA with a strong background in oncology clinical trials across all phases of development, including early phase/first-in-human studies, safety, PK/PD, and dose-escalation designs • Good computer skills and ability to embrace new technologies • Hands-on experience supporting solid tumor indications such as melanoma, breast, ovarian, prostate, and lung cancer • Phase I oncology experience is essential • Excellent communication, presentation and interpersonal skills • Basic level of critical thinking skills • Multilingual capabilities: English and German • Ability to manage required travel of up to 75% on a regular basis • Previous experience with solid tumor direct monitoring required • Traditional on-site monitoring proficiency, including full source data verification, investigational product accountability, and adherence to ICH/GCP and regulatory requirements

🏖️ 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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