Associate Clinical Research Specialist

Overview

• Contribute to clinical research initiatives, ensuring compliance with regulatory standards and internal requirements.
• Collaborate with multidisciplinary teams to manage adverse events and device deficiency reporting.
• Support clinical studies through data management, safety assessments, and regulatory documentation.
• Engage with investigational sites and clinical monitors to obtain pertinent study information.
• Ensure consistency in clinical safety event assessments and reporting processes.
• Prepare safety reports and collaborate on study-specific forms and documentation.
• Author safety management plans and facilitate Clinical Event Committee activities.
• Participate in audit preparation and database snapshot activities for clinical studies.
• Perform other clinical safety tasks as assigned to support research objectives.

Key Responsibilities & Duties

• Review and assess adverse events, serious adverse events, and device deficiencies in clinical studies.
• Collaborate with regulatory affairs and product complaint teams for timely reporting.
• Interact with investigational sites to gather additional information as per clinical investigation plans.
• Ensure appropriate distribution and notification of safety events to relevant stakeholders.
• Support the development of case report forms and study-specific safety reports.
• Assist in writing safety sections for clinical investigation plans and annual reports.
• Facilitate Clinical Event Committee work, including charter authoring and event adjudication.
• Prepare for audits and ensure data readiness for study database snapshots.
• Lead safety trending meetings and contribute to safety management planning.

Job Requirements

• Bachelor of Science degree in a relevant field such as science, nursing, or medicine.
• 1-3 years of experience in clinical research or related roles preferred.
• Proficiency with clinical databases such as RAVE and VAULT.
• Knowledge of safety event reporting and regulatory compliance standards.
• Strong analytical skills for assessing adverse events and device deficiencies.
• Excellent communication skills for interacting with investigational sites and study teams.
• Ability to author safety management plans and contribute to regulatory documentation.
• Experience in facilitating Clinical Event Committee activities is advantageous.
• Familiarity with audit preparation and data reconciliation processes.