A Clinical Trials Coordinator manages the planning, organization, and oversight of clinical studies to ensure compliance with regulatory standards and company protocols. They coordinate with research teams, monitor patient enrollment, and maintain accurate documentation to facilitate smooth trial progress. Their role is crucial in supporting biotech companies to bring new therapies from development to market efficiently.
Develops and manages clinical trial protocols and study documents.
Responsible for creating and overseeing clinical trial protocols to ensure compliance with regulatory standards and scientific accuracy. Collaborates with cross-functional teams to develop study documents that facilitate effective trial execution and participant safety. Monitors progress and implements necessary adjustments to enhance protocol adherence and data integrity.
Coordinates participant recruitment and enrollment processes.
Coordinates participant recruitment and enrollment processes by developing targeted outreach strategies to engage diverse populations effectively. Utilizes data-driven methods to optimize recruitment efforts and ensure compliance with regulatory standards. Maintains clear communication with stakeholders to facilitate smooth enrollment and enhance overall participant experience.
Ensures regulatory compliance with FDA and GCP guidelines.
Ensures regulatory compliance by meticulously adhering to FDA and Good Clinical Practice (GCP) guidelines throughout all stages of clinical trials and product development. Monitors documentation, conducts audits, and implements corrective actions to maintain compliance and uphold the highest standards of quality and patient safety. Collaborates with cross-functional teams to interpret regulations and provide training, fostering a proactive compliance culture within the organization.
Manages trial budgets and tracks financial expenditures.
Manages trial budgets by forecasting costs, allocating resources, and ensuring adherence to financial guidelines throughout clinical studies. Tracks financial expenditures meticulously to prevent overruns and optimize spending efficiency. Suggests budget adjustments based on ongoing trial needs and financial performance insights.
Oversees data collection, entry, and quality control.
Manages the entire data lifecycle, ensuring accurate data collection and entry processes to maintain high-quality standards. Implements rigorous quality control measures to identify and rectify inconsistencies or errors promptly. Collaborates with cross-functional teams to optimize data workflows and support informed decision-making.
Communicates with investigators, sponsors, and study sites.
Effective communication with investigators, sponsors, and study sites ensures accurate information flow and project alignment. Building strong relationships facilitates timely resolution of issues and enhances collaboration throughout the study. Regular updates and feedback loops help maintain transparency and drive successful study outcomes.
Organizes and conducts study team meetings and trainings.
Coordinates and leads study team meetings to ensure clear communication and effective collaboration among all members. Designs and delivers comprehensive training sessions to enhance team skills and maintain regulatory compliance. Monitors team progress and addresses questions to promote project efficiency and data quality.
Monitors trial progress and prepares status reports.
Monitors clinical trial progress by tracking enrollment, data collection, and adherence to study protocols to ensure timely completion. Prepares comprehensive status reports highlighting key metrics, milestones, and potential issues for stakeholders. Strong attention to detail and experience with clinical trial management systems (CTMS) are essential for effective monitoring and reporting.
Handles adverse event reporting and documentation.
Responsible for managing adverse event reporting and ensuring accurate, timely documentation in compliance with regulatory standards. Monitors, collects, and analyzes data related to adverse events to support safety assessments and improve risk management processes. Collaborates with cross-functional teams to maintain data integrity and facilitate effective communication with regulatory authorities.
Supports audits and inspections by regulatory agencies.
Supports audits and inspections conducted by regulatory agencies by preparing and organizing all necessary documentation and ensuring compliance with applicable standards and regulations. Collaborates with internal teams to address any findings promptly and implements corrective actions to maintain ongoing regulatory adherence. Expertise in regulatory requirements and attention to detail are critical for effective audit support and compliance management.