CRA II

Overview CRA II – Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team applies its experience and expertise to understand customer needs and shape solutions. Whether you join a Functional Service Provider partnership or a Full-Service environment, you will collaborate with problem solvers to deliver solutions that help our customers achieve their goals. Discover what your colleagues know about working at Syneos Health. Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate performance of site and site staff and to provide recommendations regarding site-specific actions; communicates/escalates serious issues to the project team and develops action plans. Maintains working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required. Demonstrates diligence in protecting confidentiality. Assesses factors that might affect subject/patient safety and data integrity at an investigator/physician site such as protocol deviations/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. 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. Applies query resolution techniques remotely and on site, and provides guidance to site staff to drive query resolution to closure within agreed timelines. Utilizes available hardware and software to support data review and capture. Verifies site compliance with electronic data capture requirements. May perform investigational product (IP) inventory, reconciliation and storage reviews. Verifies IP has been dispensed and administered according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately labelled, imported and released/returned. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents per SOPs and the Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems to track all observations, ongoing status and action items to resolution. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities and communication to ensure project objectives, deliverables and timelines are met. Quickly adapts to changing priorities to achieve goals and targets. Acts as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. Prepares for and attends Investigator Meetings and sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (including Sponsor representation, as applicable) and attends clinical training sessions according to project requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audits and follow-up actions. Maintains working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs. Chart abstraction activities and data collection. Collaboration with sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out-of-scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and health care provider associations. 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 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 US ONLY: As part of your employment with Syneos Health, you may be deployed to sites that require certain medical and personal information to gain facility access. You may be asked to provide additional information to gain access. Compliance with site requests may be a condition of employment. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on factors such as qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Additional Information: Tasks, duties, and responsibilities as listed are not exhaustive. The Company may assign additional tasks at its discretion. The Company will determine what constitutes equivalent qualifications. The Company is committed to compliance with applicable disability acts and reasonable accommodations where appropriate. #J-18808-Ljbffr