Sr CRA

Sr CRA - Sponsor dedicated - Brazil Home Based Sr CRA - Sponsor dedicated - Brazil Home Based Description 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 so we are easier to work with and 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 about changing lives. Discover what our 29,000 employees, across 110 countries, already know: WORK HERE MATTERS EVERYWHERE We are passionate about developing our people through career development, supportive line management, technical and therapeutic area training, peer recognition and a total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our culture unites us globally, and we take care of our people. We continuously build the company we all want to work for and our customers want to work with. Diversity of thoughts, backgrounds, cultures, and perspectives creates a place where everyone feels they belong. Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management, and close‑out visits (performed on‑site or remotely) ensuring regulatory, ICH‑GCP, and Good Pharmacoepidemiology Practices (GPP) compliance. Verifies the process of obtaining informed consent and demonstrates diligence in protecting confidentiality of each subject. Assesses site processes per the Clinical Monitoring/Site Management Plan (CMP/SMP), conducts source document review, verifies clinical data entered in the CRF, and drives query resolution to closure. May perform investigational product inventory, reconciliation, and reviews of storage and security, ensuring IP is dispensed and administered per protocol. Routinely reviews the Investigator Site File (ISF), reconciles contents with the Trial Master File (TMF), and ensures archiving requirements are met. Documents activities via letters, trip reports, communication logs, and other required project documents per SOPs and the Clinical Monitoring Plan. Supports subject recruitment, retention, and awareness strategies; enters data into tracking systems of all observations and actions. Understands project scope, budgets, and timelines for own and others’ activities and communicates site‑level activities to ensure objectives and timelines are met. Acts as primary liaison with study site personnel, ensuring training and compliance with applicable requirements. Prepares for and attends investigator meetings, sponsor face‑to‑face meetings, global monitoring/project staff meetings, and clinical training sessions. Provides guidance at site and project level toward audit readiness standards and supports preparation for audit and required follow‑up actions. May provide direct supervision, training, and mentorship to junior level CRAs and assist in lead tasks under supervision of a Clinical Operations Lead. For Real World Late Phase (RWLP), the Sr. CRA II will support site activities throughout the study lifecycle, collaborate with sponsor and affiliates, and provide knowledge of local requirements for RWLP designs. Qualifications Bachelor’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. Good computer skills and ability to embrace new technologies. Excellent communication, presentation, and interpersonal skills. Moderate critical thinking skills expected. Ability to manage required travel of up to 75% on a regular basis. Get to know Syneos Health: Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 sites and 675,000+ trial patients. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The company may assign other tasks, duties, or responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed. Further, nothing herein should be construed to create an employment contract. Required skills and experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to recruitment and employment of its employees. The company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within Clinical Monitoring/CRA job family are responsible for monitoring during clinical research studies to ensure that trials are conducted in accordance with widely accepted clinical practices. This includes conducting on‑site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring. Impact and contribution: individuals with responsibility in a professional discipline or specialty may manage processes and programs and may direct work of lower level professionals. The majority of time is spent contributing to the design, implementation, or delivery of processes, programs, and policies, using knowledge and skill generally acquired through advanced education. Seniority level Mid‑Senior level Employment type Full‑time Job function Research, Analyst, and Information Technology #J-18808-Ljbffr