Experienced CRA, 1 year independent monitoring experience

🕒 October 5

🌵 Arizona – Remote

🌵 Arizona – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 of source documents and medical records • Verify clinical data entered in case report forms and resolve queries remotely and on site • Support clinical study data review and capture and verify electronic data capture compliance • Perform investigational product inventory, reconciliation, storage, security and dispensing reviews • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities and track observations, action items and resolutions • Support subject/patient recruitment, retention and awareness strategies • Manage assigned site-level activities, communications, project deliverables and timelines • Liaise with study site personnel and ensure assigned sites and project team members are trained and compliant • Attend investigator, sponsor, global monitoring and clinical training meetings • Support audit readiness, audit preparation and follow-up actions • Provide site support throughout the real-world late-phase study lifecycle • Perform chart abstraction and data collection • Collaborate with sponsor affiliates, medical science liaisons and local country staff • Train junior staff when requested • Identify and communicate out-of-scope activities and suggest potential sites based on local knowledge

🎯 Requirements

• 1 year of independent monitoring experience • Homebased US only • 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 • Ability to manage required travel of up to 75% on a regular basis • Compliance with site requests for medical and other personal information required for facility access as a condition of employment • Knowledge of local requirements for real world late phase study designs • Ability to support chart abstraction activities and data collection

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Company car or car allowance • Medical, Dental and Vision health benefits • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) and sick time

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