Clinical Research Associate (CRA II - Sr CRA), Full-Service, Home-Based in Western US

📋 Description

• • As a Clinical Research Associate (CRA II - Sr CRA) at Syneos Health, you will play a pivotal role in the full-service clinical development of biopharmaceutical solutions, directly contributing to accelerating customer success and bringing life-changing therapies to patients.
• • You will be responsible for a comprehensive range of site management and monitoring activities, ensuring the highest standards of regulatory compliance, ICH-GCP, and protocol adherence throughout the clinical study lifecycle.
• • Your primary duties will involve performing site qualification, initiation, interim monitoring, and close-out visits, which can be conducted either on-site or remotely, demonstrating adaptability and a commitment to efficient study conduct.
• • You will exercise sound judgment and leverage your experience to meticulously evaluate the overall performance of clinical trial sites and their staff, providing actionable recommendations and immediately escalating any serious issues to the project team while developing robust action plans.
• • Maintaining a thorough and up-to-date understanding of ICH/GCP Guidelines, relevant regulatory requirements, and Syneos Health's Standard Operating Procedures (SOPs) and processes is crucial for success in this role.
• • A key responsibility includes verifying that the informed consent process has been adequately performed and documented for each subject, demonstrating a strong commitment to patient rights and ethical research practices.
• • You will diligently protect the confidentiality of each subject/patient, ensuring their privacy is maintained throughout the study.
• • Assessing factors that could potentially impact subject/patient safety and the integrity of clinical data at investigator sites, such as protocol deviations/violations and pharmacovigilance issues, will be a regular part of your work.
• • In accordance with the Clinical Monitoring/Site Management Plan (CMP/SMP), you will assess site processes, conduct thorough Source Document Reviews (SDR) of relevant medical records, and verify the accuracy and completeness of clinical data entered into Case Report Forms (CRFs).
• • You will be proficient in applying query resolution techniques, both remotely and on-site, providing essential guidance to site staff to drive query closure within agreed-upon timelines.
• • Utilizing available hardware and software to support the effective review and capture of clinical study data will be integral to your daily tasks, ensuring data quality and integrity.
• • You will verify that sites comply with electronic data capture (EDC) requirements, staying abreast of technological advancements in clinical research.
• • Depending on the study needs, you may be involved in investigational product (IP) inventory, reconciliation, and ensuring proper storage and security.
• • You will verify that the IP has been dispensed and administered to subjects/patients strictly according to the protocol, and assess any issues or risks associated with blinded or randomized information related to the IP.
• • Applying your knowledge of GCP/local regulations and organizational procedures, you will ensure the IP is appropriately (re)labelled, imported, and released/returned, maintaining meticulous records.
• • Routinely reviewing the Investigator Site File (ISF) for accuracy, timeliness, and completeness, and reconciling its contents with the Trial Master File (TMF), is a critical component of your role.
• • You will ensure the investigator/physician site is fully aware of the archiving requirements for essential documents in accordance with local guidelines and regulations.
• • Documenting all activities meticulously via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and the Clinical Monitoring Plan/Site Management Plan is essential for audit trails and project continuity.
• • You will actively support subject/patient recruitment, retention, and awareness strategies, contributing to the overall success of the trial.
• • Entering data into tracking systems as required to monitor all observations, track ongoing status, and ensure assigned action items are resolved promptly.
• • For your assigned activities, you will possess a clear understanding of project scope, budgets, and timelines, managing site-level activities and communication to ensure project objectives and deliverables are met on schedule.
• • You must demonstrate the ability to quickly adapt to changing priorities and effectively manage multiple tasks to achieve goals and targets in a dynamic environment.
• • You may act as the primary liaison with study site personnel, or collaborate closely with Central Monitoring Associates, ensuring seamless communication and coordination.
• • You will ensure all assigned sites and project-specific site team members receive appropriate training and remain compliant with all applicable requirements.
• • Preparing for and actively participating in Investigator Meetings and/or sponsor face-to-face meetings will be part of your responsibilities.
• • You will participate in global clinical monitoring/project staff meetings, including sponsor representation as applicable, and attend clinical training sessions as required by project-specific needs.
• • Providing guidance at both the site and project level towards audit readiness standards and actively supporting preparation for audits and subsequent follow-up actions will be expected.
• • For Real World Late Phase studies, you will operate under the business card title of Site Management Associate II (SMA II), supporting the entire study lifecycle from site identification through close-out.
• • In this capacity, you will demonstrate knowledge of local requirements for real-world late phase study designs, conduct chart abstraction activities, and perform data collection.
• • You will collaborate effectively with Sponsor affiliates, Medical Science Liaisons, and local country staff.
• • The SMA II may be requested to train junior staff, sharing expertise and fostering team development.
• • You will proactively identify and communicate out-of-scope activities to the Lead CRA/Project Manager.
• • Furthermore, you will proactively suggest potential sites based on your local knowledge of treatment patterns, patient advocacy groups, and Healthcare Provider (HCP) associations, contributing to site selection efficiency.
• • This role is home-based in the Western US, requiring the ability to manage your work effectively from a remote location while traveling up to 75% of the time.