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
Requirements
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
Certified Clinical Research Associate (CCRA) or equivalent certification preferred
Attention to detail and strong analytical skills
Problem-solving abilities and critical thinking
Ability to work effectively in a team environment
Strong organizational and time management skills
Proficiency in Microsoft Office Suite
Benefits
company car or car allowance
Health benefits to include Medical, Dental and Vision
Company match 401k
eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
flexible paid time off (PTO) and sick time
compliance with applicable federal, state, and municipal paid sick time requirements
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical research monitoringGood Clinical Practice (GCP)regulatory requirementsmonitoring planscheckliststemplatesstandard operating procedures (SOPs)monitoring reportsclinical trial management systemsMicrosoft Office Suite
Soft skills
communication skillsinterpersonal skillsindependenceproblem-solvingcritical thinkingteamworkorganizational skillstime managementattention to detailanalytical skills