# CRA II or SR CRA **Company**: Syneos Health **Work arrangement**: remote **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/BRA-Remote/CRA-II---SR-CRA-Brazil_25109156?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_d78e15e4-ee5 ## Description Syneos Health is seeking a CRA II or SR CRA to work from home in Brazil. The successful candidate will have a hiring bonus. Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. The CRA II or SR CRA will be responsible for: - Performing site qualification, site initiation, interim monitoring, site management and close-out visits - Evaluating overall performance of site and site staff and providing recommendations regarding site-specific actions - Maintaining a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes - Verifying the process of obtaining informed consent has been adequately performed and documented for each subject/patient - Assessing factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site - Conducting Source Document Review of appropriate site source documents and medical records - Applying query resolution techniques remotely and on site, and providing guidance to site staff as necessary - Utilizing available hardware and software to support the effective conduct of the clinical study data review and capture - Verifying site compliance with electronic data capture requirements - Performing investigational product (IP) inventory, reconciliation and reviews storage and security - Routinely reviewing the Investigator Site File (ISF) for accuracy, timeliness and completeness - Documenting activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents - Supporting subject/patient recruitment, retention and awareness strategies - Entering data into tracking systems as required to track all observations, ongoing status and action items to resolution - Understanding project scope, budgets, and timelines for own and others' activities in the clinical team - Managing site-level activities / communication to ensure project objectives, deliverables and timelines are met - Acting as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate - Preparing for and attending Investigator Meetings and/or sponsor face to face meetings - Providing guidance at the site and project level towards audit readiness standards and supporting preparation for audit and required follow-up actions - May provide direct supervision, training and/or mentorship to more junior level CRAs The ideal candidate will have: - 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 level of critical thinking skills expected - Ability to manage required travel of up to 75% on a regular basis Benefits: Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition and total rewards program. ## Skills ### Required - Good Clinical Practice - ICH Guidelines - regulatory requirements - computer skills - communication skills - interpersonal skills - critical thinking --- Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/BRA-Remote/CRA-II---SR-CRA-Brazil_25109156?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)