Clinical Research Associate II (CRA II)

Our client, a renowned pharmaceutical company, is seeking a dedicated Clinical Research Associate II (CRA II) to join their team, offering a hybrid work arrangement in Virginia Beach, Virginia, US . This vital role supports the execution of clinical trials by monitoring study sites, ensuring adherence to protocols, and maintaining data integrity. The CRA II will be responsible for initiating, monitoring, and closing out clinical trial sites, ensuring compliance with Good Clinical Practice (GCP), FDA regulations, and other applicable guidelines. You will conduct site visits, including qualification, initiation, interim monitoring, and close-out visits, to verify data accuracy, review regulatory documents, and assess patient safety. The ideal candidate possesses strong organizational skills, excellent communication abilities, and a thorough understanding of clinical trial processes. You will serve as a key point of contact for investigators and site staff, providing support and guidance throughout the trial lifecycle. This hybrid role balances on-site responsibilities with remote work capabilities, allowing for efficient management of your territory. Responsibilities:
Perform site qualification, initiation, monitoring, and close-out visits. Ensure adherence to study protocols, GCP, and regulatory requirements. Verify the accuracy and completeness of clinical trial data. Review source documents and patient records to ensure data integrity. Train and support site staff on study procedures and requirements. Manage study-related supplies and equipment at sites. Prepare and submit monitoring reports in a timely manner. Identify and resolve site-specific issues and deviations. Maintain effective communication with investigators, site staff, and internal project teams. Ensure timely collection of regulatory documents and essential trial documents. Qualifications:
Bachelor's degree in a life science, nursing, or related field. Minimum of 3 years of experience as a Clinical Research Associate. Thorough understanding of GCP, ICH guidelines, and regulatory requirements. Experience with various therapeutic areas is a plus. Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems. Excellent communication, interpersonal, and organizational skills. Ability to travel to clinical sites as required (up to 60%). Strong attention to detail and ability to manage multiple priorities. Ability to work independently and as part of a remote/hybrid team. RN or equivalent clinical experience is advantageous. This is an excellent opportunity for an experienced CRA to contribute to critical clinical research initiatives in Virginia Beach, Virginia, US , with a flexible hybrid work model.

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