Senior CRA II – Site Care Partner, Oncology

🔥 0 minutes ago

🇦🇷 Argentina – Remote

⏰ Full Time

🟠 Senior

🪙 Affiliate Manager

👻 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, provide recommendations, escalate serious issues and develop action plans • Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity • Assess site processes and conduct source document review and medical-record verification • Resolve queries remotely and on site within agreed timelines • Use hardware and software for clinical study data review and capture; verify electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, security, dispensing and administration compliance • Review Investigator Site Files and reconcile them with the Trial Master File • Document monitoring activities and maintain tracking systems • Support subject/patient recruitment, retention and awareness strategies • Manage site-level activities and communications to meet project objectives, deliverables, budgets and timelines • Liaise with study site personnel and ensure assigned sites and project-specific staff are trained and compliant • Attend Investigator Meetings, sponsor meetings, clinical monitoring/project staff meetings and training sessions • Support audit readiness, audit preparation and follow-up actions • Provide supervision, training and mentorship to junior CRAs; perform training and sign-off visits • Support RWLP activities including site support, chart abstraction, data collection, regulatory collaboration, site identification, process improvement, consent-form development, RFPs, budgeting, site management strategy and CRF/edit-check development

🎯 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 • Good computer skills and ability to embrace new technologies • Excellent communication, presentation and interpersonal skills • Moderate level of critical thinking skills • Ability to manage required travel of up to 75% on a regular basis • Experience in oncology is ideally preferred by the title, but not stated as a mandatory qualification

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Reasonable accommodations, when appropriate, for employees or applicants with disabilities