Clinical Trial Associate - Level II
ALLEN SPOLDEN - Raleigh, NC
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Job Description Join a dynamic and innovative pharmaceutical organization as a Clinical Trial Associate (CTA), and play a crucial role in driving the operational strategy and execution of transformative clinical studies. In this engaging role, you will be pivotal to the Clinical Development Plan, ensuring that daily clinical activities are executed seamlessly. Assist in essential clinical study tasks, ensuring readiness for regulatory inspections while adhering to established protocols under the mentorship of the CTA Manager. Collaborate effectively with the Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to facilitate smooth execution of clinical study activities following the clinical trial operating model. Execute departmental tasks efficiently and effectively. Engage in developmental opportunities with guidance from the CTA Manager to foster professional growth. ACCOUNTABILITIES: For assigned complex, accelerated, and critical studies, focus on supporting start-up and site initiation activities: Approve vital study documents, including essential document packets, study plans, and informed consent forms. Support oversight of risk-based monitoring during studies. Participate in key team meetings to promote collaboration. Prepare for regulatory inspections by organizing materials and participating actively. Assist with additional ad-hoc tasks as discussed with the CTA Manager. Work cross-functionally with internal departments, including Legal, Insurance, R&D functions, CROs, and vendors. Address and escalate clinical trial insurance matters as necessary. Assist in vendor contract administration to ensure efficient operational processes. Requirements Associate or Bachelor's degree in Life Sciences or Healthcare. A minimum of 2 years of experience in the pharmaceutical industry, clinical research organization, or a related role. Experience in Phase 2 and 3 studies as well as global/international studies is highly desirable. Exposure to diverse therapeutic areas is a plus. Strong knowledge of global regulatory and compliance requirements for clinical research. Exceptional organization and collaboration skills. Willingness to travel domestically and internationally (5-10%) as necessary, including overnight trips. Benefits 401(k) plan with company matching and an Annual Retirement Contribution Plan. Tuition reimbursement and company match for charitable contributions. Generous time-off policy for vacations, with the option to purchase additional vacation days.
Created: 2026-03-13