Senior Clinical Research Associate, Brazil

🔥 4 hours ago

🇧🇷 Brazil – 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 study site management to protect patient safety and ensure high-quality data • Provide site- and project-level guidance for 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 deviations and pharmacovigilance issues • Conduct pre-study, qualification, initiation, routine monitoring and close-out visits, including monitoring oversight visits • Prepare timely monitoring reports and required study documentation • Support patient recruitment, retention and awareness strategies • Review and reconcile Investigator Site Files with Trial Master Files • Communicate study issues to site personnel and Precision project and clinical trial management teams • Manage investigational product inventory, reconciliation, storage, dispensing and regulatory compliance • Perform EDC/CRF and patient-profile data reviews, resolve queries and support data discrepancy resolution • Identify and process Serious Adverse Events according to study procedures • Identify site risks, escalate them with contingencies and own timely resolution with project oversight • 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 proposals and client presentations • Initiate investigator payment requests • Travel as needed according to project requirements

🎯 Requirements

• 4-year college degree or equivalent experience in a scientific or healthcare discipline • 5 years or more as a CRA in 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 English proficiency, verbally and in writing • Experience monitoring rare and complex therapeutic areas (preferred) • Experience monitoring EDC trials and EHR records (preferred) • Experience in biopharma or relevant therapeutic area (preferred) • Relevant country-specific site start-up experience (preferred) • Ability to monitor study sites according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines (preferred) • Ability to travel overnight; up to 60% travel on average, with international travel as needed (preferred) • Oncology experience, preferably in early phases, for select opportunities (preferred) • Understanding of clinical trial methodology, protocols and indications (preferred) • Ability to conduct formal presentations proficiently (preferred)

🏖️ Benefits

• Remote work in Brazil • Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities