Senior Clinical Research Associate

🔥 5 minutes ago

🇨🇱 Chile – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 19%

What it means: how likely this posting is sitting open without active hiring.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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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Oversee all aspects of study site management to protect patient safety and maintain data quality • Provide site- and project-level guidance toward audit readiness and support audit follow-up actions • Maintain study-specific trial management tools, systems, and status reports • Manage site start-up, including investigator feasibility and recruitment, EC/IRB submissions, regulatory documents, informed consents, notifications, translations, and meetings • Assist with study budget negotiations and investigator contracts when required • Verify informed-consent processes and assess patient-safety, data-integrity, protocol-deviation, and pharmacovigilance issues • Conduct pre-study, qualification, initiation, routine monitoring, close-out, and monitoring oversight visits, both on-site and remotely • Prepare timely monitoring reports and required project documentation • Support patient recruitment, retention, and awareness strategies • Review and reconcile Investigator Site Files with Trial Master Files • Communicate study issues with site personnel and Precision project and clinical trial management teams • Maintain relationships with investigators and study staff • Manage investigational-product inventory, reconciliation, storage, dispensing, and regulatory compliance • Perform remote EDC/CRF and patient-profile reviews, resolve queries, and assist with data discrepancies • Identify and process Serious Adverse Events • Identify site risks, escalate them, and oversee timely resolution • Attend investigator, sponsor, global monitoring, and clinical training meetings • Assist with protocols, study documentation, CRF design, clinical trial documents, and clinical study reports • Mentor and train new employees and junior monitors • Interact with clients and participate in proposal activities and presentations • Initiate investigator payment requests • Travel as required by project needs

🎯 Requirements

• 4-year college degree or equivalent experience in a scientific or healthcare discipline • 5 years or more as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies • Significant site management experience or equivalent experience in clinical research • Professional-level proficiency in English, verbally and in writing • Preferred: graduate or postgraduate degree • Preferred: experience monitoring rare and complex therapeutic areas • Preferred: experience monitoring EDC trials and EHR records • Preferred: experience in biopharma or a relevant therapeutic area • Preferred: relevant country-specific site start-up experience, including feasibility, contract negotiations, and submissions • Preferred: ability to monitor sites according to protocol monitoring guidelines, SOPs, GCP, and ICH guidelines • Preferred: ability to resolve project-related problems and prioritize workload • Preferred: ability to travel overnight; up to 60% travel on average and international travel as needed • Preferred for select opportunities: oncology experience, preferably in early phases • Preferred: understanding of clinical trial methodology, protocols, and indications • Preferred: ability to conduct formal presentations • Preferred: continuous improvement and process-efficiency skills