Senior Clinical Research Associate - Biotech

We are seeking a Senior Clinical Research Associate to perform monitoring and site management work, ensuring sites conduct studies and report data according to the study protocol, regulations, and sponsor requirements.

Essential Functions

• Conduct site monitoring visits, including selection, initiation, monitoring, and close-out visits, following contracted scope of work and regulatory requirements
• Collaborate with sites to adapt, drive, and track subject recruitment plans, enhancing predictability
• Provide protocol and study-related training to assigned sites, establishing regular communication lines to manage project expectations and issues
• Evaluate study site practices, ensuring proper conduct of the protocol and adherence to regulations, escalating quality issues as needed
• Manage study progress, tracking regulatory submissions, recruitment, case report form completion, and data query resolution
• Ensure site documents are available for filing in the Trial Master File and verify Investigator's Site File maintenance
• Create and maintain documentation regarding site management, monitoring visit findings, and action plans
• Collaborate with study team members for project execution support

Qualifications

• Bachelor's degree in a scientific discipline or healthcare preferred
• At least 1 year of on-site monitoring experience
• Equivalent combinations of education, training, and experience may be accepted
• Good knowledge of and skill in applying clinical research regulatory requirements, such as GCP and ICH guidelines
• Therapeutic and protocol knowledge, as provided in company training
• Computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint, and use of a laptop computer and iPhone and iPad where applicable
• Written and verbal communication skills, with good command of English
• Organizational and problem-solving skills, effective time and financial management skills, and ability to establish and maintain effective working relationships