Site Care Partner – Min 6+ years monitoring experience, ideally in Oncology

🕒 September 4

🇦🇷 Argentina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🪙 Affiliate Manager

👻 Ghost score 34%

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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 and action plans • Communicate and escalate serious issues to the project team • Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity • Conduct source document review and verify clinical data accuracy and completeness • 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 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, status and action items through resolution • Manage site-level activities and communications to meet project objectives, deliverables and timelines • Liaise with study site personnel and Central Monitoring Associates • Train assigned sites and project-specific site team members • Attend Investigator Meetings, sponsor meetings, clinical monitoring meetings and training sessions • Support audit readiness, audits and follow-up actions • Supervise, train and mentor junior CRAs; perform training and sign-off visits • For RWLP, support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsors and affiliates, suggest potential sites, develop informed consent forms, support regulatory updates, participate in bid defense and RFP activities, and contribute to CRF design and edit-check development

🎯 Requirements

• Minimum 6+ years of previous monitoring experience • Oncology monitoring experience ideally • 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 • Working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes • Ability to perform site qualification, initiation, monitoring, management and close-out activities in compliance with applicable standards • Ability to work with clinical data, source documents, case report forms, electronic data capture systems, Investigator Site Files and Trial Master Files

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Total Self culture supporting authenticity and belonging • Diversity, equity and inclusion-focused workplace culture • Remote work arrangement (Remote (Pre-Approved))