Clinical Research Associate II / Sr CRA - Full Service - (Home-Based in Central US) (Open)

Updated: February 19, 2026 Location: Morrisville, NC, United States Job ID: 25102606 Not reputed company to apply? Join our Talent Network Description Clinical Research Associate II / Sr CRA - Full Service - (Home-Based in Central US) (Open) reputed company® is a leading fully integrated biopharmaceutical solutions organization built to accelerate reputed company. We translate unique clinical, medical affairs and reputed company insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center 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 a team 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 MATTERS EVERYWHERE Why reputed company

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we reputed company want to work for and our customers want to work with. Why? Because reputed company we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re reputed company to create a reputed company where everyone feels like they belong. Job Responsibilities
• Performs site qualification, site initiation, interim monitoring, site management activities and reputed company-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 overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action 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 each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each 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 form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution 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 dispensed 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, trip 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 track reputed company observations, ongoing status and assigned action items to resolution.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be reputed company to quickly adapt to changing priorities to reputed company goals / targets.
• May

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