Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms
Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates
Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials
Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress, and resolving issues
Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow-up letters, and action plans
Collaborate with cross-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conduct
Qualifications
Bachelor's degree in a related field or equivalent experience
Minimum of 2-4 years of experience in clinical research monitoring
Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
Excellent communication and interpersonal skills
Ability to work independently and manage multiple priorities
Proficiency in using clinical trial management systems and other relevant software
