Experienced Clinical Research Associate - Full-Service- West Coast

Experienced Clinical Research Associate - Full-Service- West Coast Updated: April 16, 2026 Location: Morrisville, NC, United States Job ID: 25107805 Description Experienced Clinical Research Associate responsible for site qualification, initiation, monitoring, management, and close-out visits (on-site or remote) to ensure regulatory, ICH-GCP, and protocol compliance. Responsible for assessing site performance, communicating issues to the project team, and developing action plans. Maintains knowledge of relevant guidelines, regulations, and company SOPs/processes. Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Evaluates site performance and staff, provides recommendations on site actions, and escalates serious issues with action plans. Maintains knowledge of ICH/GCP Guidelines, applicable regulations, and SOPs/processes. Verifies informed consent processes and documentation for each subject, protects subject confidentiality, and assesses factors affecting subject safety and data integrity (protocol deviations/violations, pharmacovigilance issues). Assess site processes per the CMP/SMP; conduct Source Document Review; verify accuracy/completeness of data entered into the CRF; apply query resolution techniques remotely and on-site; support data review and capture; verify compliance with electronic data capture requirements. May perform investigational product (IP) inventory, reconciliation, storage and security review; verify IP dispensing/administration per protocol; manage IP-related blinding or randomization information; ensure appropriate labeling, import, release/return. Review Investigator Site File (ISF) for accuracy; reconcile with Trial Master File (TMF); ensure archiving of essential documents per local guidelines and regulations. Document activities via letters, reports, logs, and other project documents; support subject recruitment/retention; enter data into tracking systems for observations, status, and actions. Understand project scope, budgets, and timelines; manage site-level activities/communication to meet objectives; adapt to changing priorities as needed. May act as primary liaison with study site personnel or in collaboration with Central Monitoring Associate; ensure sites and team members are trained and compliant with applicable requirements. Prepare for and participate in Investigator Meetings and sponsor meetings; attend clinical training sessions as required; contribute to audit readiness and follow-up actions. Maintain knowledge of ICH/GCP Guidelines and applicable regulations; complete assigned training as required. Qualifications Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Good computer skills and ability to adopt new technologies Excellent communication, presentation and interpersonal skills Ability to manage required travel of up to 75% on a regular basis #J-18808-Ljbffr