Experienced Clinical Research Assoc...

Join Syneos Health, a fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We are seeking an experienced Clinical Research Associate (CRA) to oversee and ensure the integrity of clinical research studies across the United States. This role involves meticulous monitoring of data and processes, ensuring strict compliance with all regulatory requirements and clinical protocols. The ideal candidate will leverage their expertise to conduct site qualification, initiation, interim monitoring, site management, and close-out visits, performing these duties both on-site and remotely. You will critically evaluate site and staff performance, escalate critical issues, and develop proactive action plans. Maintaining a strong working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs is essential. Responsibilities include verifying informed consent processes, protecting patient confidentiality, assessing potential risks to patient safety and data integrity, and conducting source document reviews. You will ensure the accuracy and completeness of case report forms (CRFs), drive query resolution, and utilize electronic data capture systems effectively. Additionally, you may be involved in investigational product (IP) management, including inventory, reconciliation, storage, and dispensing verification. Maintaining the Investigator Site File (ISF) and reconciling it with the Trial Master File (TMF) are key duties. Documentation of all activities through various project documents is required. The CRA will manage site-level activities to meet project objectives, timelines, and budgets, adapting quickly to changing priorities. You will serve as a primary liaison with study site personnel, ensuring all assigned sites and project teams are trained and compliant. Preparation for and participation in Investigator Meetings and global project staff meetings are expected, along with contributing to audit readiness and follow-up actions. For Real World Late Phase studies, the role may be titled Site Management Associate II, involving site support, chart abstraction, data collection, and collaboration with local country staff. The ability to proactively suggest potential sites based on local knowledge is also valued.