Senior Clinical Research Associate, Chile

🔥 3 hours ago

🇨🇱 Chile – 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

• Independently 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 preparation and follow-up • 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 assess patient safety, data integrity, protocol deviations, violations, 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 document activities according to SOPs, monitoring plans, and client requirements • Support patient recruitment, retention, and awareness strategies; track observations and action items to resolution • Review Investigator Site Files and reconcile them with Trial Master Files • Communicate study issues to site personnel and Precision project and clinical trial management teams • Build relationships with investigators and study staff while representing Precision’s professional image • Manage investigational product inventory, reconciliation, storage, security, dispensing, administration, labeling, import, and return/release compliance • Perform EDC CRF and patient-profile data reviews, resolve queries, and assist with data discrepancies • Identify and process Serious Adverse Events according to study procedures • Identify site risks, escalate them, and own timely resolution with project-team oversight • Attend investigator, sponsor, global monitoring, and clinical training meetings • Assist with protocols, study documentation, CRF design, monitoring materials, 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 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 • Professional-level English communication skills, both verbal and written • Experience monitoring rare and complex therapeutic areas • Experience monitoring EDC trials and EHR records • Experience in biopharma or a 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 travel overnight; up to 60% travel on average, with international travel as needed • Oncology experience may be required for select opportunities, preferably in early phases • Understanding of clinical trial methodology, protocols, and study indications • Ability to conduct formal presentations to colleagues, investigative staff, and clients • Ability to work and plan independently and in a team environment

🏖️ Benefits

• Remote work arrangement • Equal opportunity employment • Reasonable accommodation for applicants with disabilities