Senior Clinical Research Associate

New Role - Snr CRA - Small CRO - US Only Key Responsibilities Independently perform site selection, initiation, routine monitoring, and close-out visits in accordance with the protocol, ICH-GCP, and applicable regulations Conduct/oversee remote and on-site monitoring visits, ensuring source data verification, informed consent compliance, and data quality Manage a defined caseload of sites with minimal supervision, ensuring enrollment, timelines, and quality metrics are met Serve as primary site contact, building strong relationships with investigators and site staff Identify and resolve site-level issues, escalating risks to the Clinical Team Lead/PM as appropriate Review and ensure completeness of essential documents/TMF in line with ICH-GCP and company SOPs Support development of monitoring plans, visit report templates, and site management tools Mentor and provide guidance to junior CRAs and CRA-in-training staff Contribute to audit/inspection readiness at site and study level Liaise directly with sponsors on site status, risk mitigation, and study progress as needed Support process improvement initiatives given the CRO's smaller, evolving infrastructure Requirements Bachelor's degree in life sciences, nursing, or related field (or equivalent experience) Minimum 3–5 years' CRA experience, including independent on-site monitoring (CRO, sponsor, or site-based) Strong working knowledge of ICH-GCP, FDA/EMA (or relevant regional) regulations Proven track record managing a full monitoring visit caseload independently Experience in [therapeutic area, if relevant] preferred Excellent communication and site relationship management skills Ability to work autonomously in a smaller, less hierarchical company structure Willingness to travel 30% for on-site visits (region-dependent) Experience mentoring junior staff is a plus #J-18808-Ljbffr