Senior Clinical Research Associate

Accountabilities:

• Execute site monitoring activities including qualification, initiation, interim, and close-out visits, ensuring compliance with protocols, ICH-GCP, and regulatory standards

• Manage site relationships, maintaining effective communication and supporting issue resolution throughout the study lifecycle

• Conduct oversight monitoring activities, including review of CRO CRA performance, study metrics, and site-level deliverables

• Perform drug accountability, reconciliation, and ensure proper handling, storage, and destruction processes

• Review source documentation and ensure accurate and complete data capture aligned with ALCOA principles

• Prepare, write, and submit detailed monitoring visit reports, oversight reports, and study correspondence

• Identify protocol deviations, escalate non-compliance issues, and ensure appropriate corrective actions are implemented

• Collaborate with clinical teams, CTLs, and CRO partners to support study activation, execution, and inspection readiness

Requirements:

• Bachelor’s degree or equivalent in a scientific or health-related field

• Minimum of 5 years of experience as a Clinical Research Associate or in a related clinical research role

• Strong knowledge of clinical drug development processes and ICH-GCP guidelines

• Familiarity with regulatory frameworks such as FDA, EMA, and PMDA requirements

• Experience with clinical systems including EDC, CTMS, and Microsoft Office applications

• Strong analytical thinking, problem-solving skills, and attention to detail

• Excellent communication and interpersonal skills to manage stakeholder relationships effectively

• Strong organizational skills with the ability to prioritize tasks and manage travel-intensive workloads

• Ability to produce clear, concise, and high-quality written reports

Benefits:

• Competitive compensation aligned with experience and market standards

• Comprehensive health, dental, and vision insurance coverage

• Retirement savings plans with employer contributions

• Flexible work arrangements with significant travel opportunities across the United States

• Opportunities for professional development and continued training in clinical research

• Exposure to global clinical trials and cross-functional collaboration

• Supportive and inclusive work environment focused on innovation and impact in healthcare.

How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
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