# Sr CRA I/ II **Company**: Syneos Health **Location**: AUS-Remote **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/AUS-Remote/Sr-CRA-I--II--Melbourne--Perth---FSP_25114152?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_088c4bbb-615 ## Description Syneos Health is seeking a Sr CRA I/ II to join their Clinical Solutions team. The successful candidate will perform site qualification, site initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Responsibilities: - Perform site qualification, site initiation, interim monitoring, site management and close-out visits - Evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions - Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient - Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site - Conduct Source Document Review of appropriate site source documents and medical records - Verify required clinical data entered in the case report form (CRF) is accurate and complete - Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary - Utilize available hardware and software to support the effective conduct of the clinical study data review and capture - Verify site compliance with electronic data capture requirements - Perform investigational product (IP) inventory, reconciliation and reviews storage and security - Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness - Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents - Support subject/patient recruitment, retention and awareness strategies - Enter data into tracking systems as required to track all observations, ongoing status and action items to resolution - Understand project scope, budgets, and timelines for own and others' activities in the clinical team - Manage site-level activities / communication to ensure project objectives, deliverables and timelines are met - Act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate - Prepare for and attend Investigator Meetings and/or sponsor face to face meetings - Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions - May provide direct supervision, training and/or mentorship to more junior level CRAs 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 - Ability to manage required travel of up to 75% on a regular basis ## Skills ### Required - Good Clinical Practice - ICH Guidelines - regulatory requirements - computer skills - communication skills - interpersonal skills --- Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/AUS-Remote/Sr-CRA-I--II--Melbourne--Perth---FSP_25114152?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)