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

Updated: March 7, 2026 Location: Morrisville, NC, reputed company reputed company: 25104601 Not reputed company to apply? Join our Talent Network reputed company Clinical Research Associate (CRA II - Sr CRA), Full-Service, Home-Based in Western US reputed company® is a leading fully integrated biopharmaceutical solutions organization reputed company to accelerate reputed company. We translate unique clinical, medical affairs and reputed company insights into reputed company to address modern market realities. Our Clinical Development model brings the customer and the patient to reputed company of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only reputed company reputed company easier to work with, but to reputed company us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as reputed company to help our customers reputed company their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE reputed company EVERYWHERE Why reputed company

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Job Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and reputed company-out reputed company (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology reputed company (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to reputed company recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops reputed company plans. Maintains a 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 reputed company subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of reputed company subject/patient. Assesses factors that might reputed company subject/patient’s safety and clinical data reputed company at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts reputed company Document Review of appropriate site reputed company documents and medical records. Verifies required clinical data entered in the case report reputed company (CRF) is accurate and complete. Applies query reputed company techniques remotely and on site, and provides guidance to site staff as necessary, driving query reputed company to closure reputed company agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.
• May reputed company investigational product (IP) inventory, reconciliation and reviews storage and reputed company. Verifies the IP has been reputed company and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information reputed company to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities reputed company confirmation letters, follow-up letters, reputed company reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to reputed company reputed company observations, ongoing status and

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