Sr CRA - Sponsor dedicated - Argentina Home Based Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do.
We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture - where you can authentically be yourself.
Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with.
Why?
Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.Job ResponsibilitiesConduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, case report forms, and regulatory documentsDevelop tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and standard operating proceduresContribute to the design, implementation, and delivery of processes, programs, and policies by providing expert input and feedback during development and review stagesDirect the work of lower-level professionals or manage processes and programs, including training and mentoring junior staff and overseeing their monitoring activitiesEnsure trials are conducted in accordance with regulatory requirements and company standards by performing regular audits and inspections, and addressing any compliance issues that ariseProvide guidance and support to clinical research teams, including answering questions, resolving issues,



and facilitating communication between team members and stakeholdersMaintain accurate and timely documentation of monitoring activities, including writing detailed monitoring reports, tracking study progress, and updating databasesIdentify and resolve issues related to clinical trial conduct, such as protocol deviations, data discrepancies, and adverse events, and implement corrective and prevenes, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools.Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan.Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan.
Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity.Document requested revisions and approvals in CTMS.
Ensures these deliverables are provided according to company and/or sponsor specifications,



including delivery deadlines.Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables.
Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements.Provides solutions for obstacles in protocol execution and site management.
Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.
This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA).
Supports Inspection Readiness for clinical trial management scope.
Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks.
May develop and support execution of corrective action plans at site and study level.Supports and completes activities to achieve data cut and lock deadlines.
Provides feedback to line managers on staff performance including strengths as well as areas for development.
May be assigned to larger,more complex trials.QualificationsBachelor's degree or RN in a related field or equivalent combination of education, training and experienceDemonstrated ability to lead and align teams in the achievement of project milestonesDemonstrated capability of working in an international environmentDemonstrated expertise in site management and monitoring (clinical or central)Preferred experience with risk-based monitoringDemonstrates understanding of clinical trial management financial principles and budget managementKnowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirementsMust demonstrate good computer skillsGood communication, presentation and interpersonal skills among project team and with sitesStrong conflict resolution skillsDemonstrated ability to apply problem solving techniques to resolve complex issues, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical m CRAs to senior management, is skilled in the same therapeutic area or customer teams.
With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population.
We are partners with purpose.
We integrate seamlessly with our customers and do what's best for their success.
Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.
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📌 Sr Cra - Sponsor Dedicated - Argentina Home Based (Santa Fe)
🏢 7257 Syneos Health Argentina
📍 Santa Fe