Senior Clinical Research Associate, Brazil

🔥 1 minute ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Oversee all aspects of study site management to protect patient safety and ensure high-quality data • Provide guidance on audit readiness and support audit preparation and follow-up actions • Maintain study-specific trial management tools, systems, and status reports • Manage site start-up, investigator feasibility and recruitment, EC/IRB submissions, regulatory documents, informed consents, notifications, translations, and meetings • Assist with study budget negotiations and investigator contract execution when required • Verify informed consent processes and documentation; assess patient safety, protocol deviations, pharmacovigilance issues, and data integrity • Conduct pre-study, qualification, initiation, routine monitoring, close-out, and monitoring oversight visits, both on-site and remotely • Prepare timely and accurate monitoring reports and required project documentation • Support patient recruitment, retention, and awareness strategies • Review Investigator Site Files and reconcile them with Trial Master Files • Communicate study issues and risks to site personnel, Clinical Trial Managers, and Project Managers; implement resolutions • Maintain relationships with investigators and study staff • Manage investigational product inventory, storage, dispensing, administration, labeling, import, release, and return • Perform remote EDC CRF and patient profile reviews, resolve queries, and assist with data discrepancy resolution • Process Serious Adverse Events according to study procedures • Prepare for and attend investigator, sponsor, global monitoring, and clinical training meetings • Assist with protocol and study-document review, CRF and clinical-trial-document development, and clinical study report review • Mentor and train new employees and junior monitors • Participate in client and proposal activities, including client presentations • Initiate investigator payment requests • Travel as necessary according to 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 • Ability to communicate both verbally and in writing in English at a professional level • Experience monitoring in rare and complex therapeutic areas • Experience monitoring EDC trials and EHR records • Experience in biopharma or relevant therapeutic area • Relevant country-specific site start-up experience, including feasibility, contract negotiations, and submissions • Ability to monitor study sites according to protocol monitoring guidelines, SOPs, GCP, and ICH guidelines • Ability to resolve project-related problems and prioritize workload to meet deadlines • Ability to travel overnight; up to 60% travel on average based on regional requirements, with international travel as needed • Oncology experience, preferably in early phases, for select opportunities • Understanding of clinical trial methodology, protocols, and indications • Demonstrated ability to conduct formal presentations for colleagues, investigative staff, and clients • Demonstrated focus on continuous improvement

🏖️ Benefits

• Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities • Data provided during application stored according to the Privacy Policy