Clinical Study Associate II

. What You’ll Do Support the Clinical Operations Study Leader and team in managing and overseeing clinical trials. Reports to an Associate Director of Clinical Operations (or above). Responsibilities • Assist in day-to-day trial execution: site start-up, enrollment, monitoring, and data flow. • Prepare study documents (consent forms, site instructions, manuals, pharmacy binders). • Track essential documents in TMF; review site documents for accuracy. • Monitor patient status and sample collection; manage lab schedules and vendor coordination. • Liaise with CROs and sites for sample handling and reporting. • Review monitoring reports, data queries, and site performance metrics. • Attend site visits and co-monitor with CRO. • Ensure data quality and resolve eligibility/protocol deviation issues. • Support investigator/vendor meetings and feasibility assessments. • Review site contracts and budgets; coordinate third-party vendor activities. . Qualifications Capabilities • Resourceful and flexible in dynamic environments. • Highly organized with strong multi-tasking skills. • Collaborative team player. • Self-Starter & Results Driven: Takes initiative, identifies opportunities, and drives deliverables with minimal supervision. • 3+ years in pharma, CRO, or clinical research environment. • Knowledge of GCP and SOPs; understanding of study phases. • Proficient in Word, Excel, PowerPoint; database management basics. • Strong verbal and written communication skills. Preferred • Medical/scientific experience in clinical research. • Experience in monitoring, study coordination, or data handling . Qualifications • Bachelor’s degree in science or higher. Apply tot his job Apply To this Job