Sr Cra - Sponsor Dedicated - Brazil Home Based

Sr CRA - Sponsor dedicated - Brazil Home BasedJoin to apply for the Sr CRA - Sponsor dedicated - Brazil Home Based role at Syneos HealthDescriptionSyneos 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.Why Syneos HealthWe 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 ResponsibilitiesPerforms site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and / or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.Verifies the process of obtaining informed consent has been adequately performed and documented for each subject / patient as required / appropriate.Assesses factors that might affect subject / patient's safety and clinical data integrity at an investigator / physician site such as protocol deviation / violations and pharmacovigilance issues.Conducts Source Document Review of appropriate site source documents and medical records.Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records.May perform investigational product (IP) inventory, reconciliation and reviews storage and security.Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan / Site Management Plan.Supports subject / patient recruitment, retention and awareness strategies.Understands project scope, budgets, and timelines for own and others' activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.Prepares for and attends Investigator Meetings and / or sponsor face to face meetings.Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.May provide direct supervision, training and / or mentorship to more junior level CRAs.QualificationsBachelor's degree or RN in a related field or equivalent combination of education, training and experience.Knowledge of Good Clinical Practice / ICH Guidelines and other applicable regulatory requirements.Must demonstrate good computer skills and be able to embrace new technologies.Excellent communication, presentation and interpersonal skills.Ability to manage required travel of up to 75% on a regular basis.Syneos Health is an Equal Employment Opportunity employer and is committed to complying with the Americans with Disabilities Act.

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