Experienced Clinical Research Associate - Sponsor Dedicated

Experienced Clinical Research Associate - Sponsor Dedicated Updated: Yesterday Location: Morrisville, NC, United States Job ID: 25109784-OTHLOC-1500-2DTX-2DR Description Responsible for site qualification, initiation, monitoring, management, and close‑out activities ensuring regulatory, ICH‑GCP and GPP compliance. Performs source document review, data verification, query resolution, IP inventory, investigator site file review, and documentation per SOPs. Provides audit readiness support, site recruitment, retention, and acts as primary liaison with study site personnel. Attends investigator and sponsor meetings and participates in global monitoring/project staff meetings. Job Responsibilities Perform site qualification, initiation, interim monitoring, site management activities and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP and/or GPP compliance. Verify informed consent process, protect subject confidentiality, and assess factors affecting safety and data integrity. Assess site processes, conduct source document review, verify CRF data accuracy, resolve queries, and ensure eCRF compliance. Perform IP inventory, reconcile storage/safety, ensure correct dispensing and handling. Review Investigator Site File for accuracy, reconcile with Trial Master File, and ensure archiving compliance. Document activities via letters, reports, logs per SOPs; support recruitment, retention, and data tracking. Manage site‑level activities, budgets, and timelines; adapt to changing priorities. Serve as primary liaison with site personnel; ensure training and compliance. Prepare for and attend investigator and sponsor meetings; participate in training sessions. Provide guidance toward audit readiness and support audit preparation and follow‑up. Maintain knowledge of ICH/GCP Guidelines and company SOPs; complete training as required. (Additional responsibilities include real‑world late‑phase study support, chart abstraction, data collection, hiring junior staff, identifying out‑of‑scope activities, and suggesting potential sites.) 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 embrace new technologies. Excellent communication, presentation and interpersonal skills. Ability to manage required travel of up to 75% on a regular basis. US ONLY: compliance with deployment medical information requirements as described. Summary Roles within Clinical Monitoring/CRA oversee and ensure the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes remote monitoring of trial sites to verify compliance, utilizing data analytics and risk‑based monitoring to identify potential issues, and collaborating with site teams to implement quality enhancements. Benefits Benefits may include a company car or car allowance; health benefits including medical, dental, and vision; company match 401(k); participation in Employee Stock Purchase Plan; eligibility to earn commissions/bonuses; and flexible paid time off and sick time. Eligibility for paid sick time may vary by state. Salary Range The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Equal Employment Opportunity Syneos Health complies with all applicable federal, state, and municipal laws regarding paid sick time. The Company is committed to compliance with the Americans with Disabilities Act, including providing reasonable accommodations when appropriate. #J-18808-Ljbffr