Clinical Research

• Act as study coordinator to execute trials conducted within physician practices
• Visit preparation activities
• Visit follow-up activities
• Supply and inventory management
• Third party vendor coordination
• Conduct patient recruitment and enrollment of eligible patients
• Conduct patient study visits, which may include clinical and lab procedures such as ECG, phlebotomy, vital signs and body measurements, laboratory processing
• Independently administer the informed consent process with care and quality
• Ensure protocol adherence and high data integrity
• Provide high quality source data capture and documentation
• Attend study start-up and planning meetings, including PSVs and SIVs
• Facilitate monitoring visits (IMVs) and sponsor correspondence and follow-up items
• IP management, dispensation and accountability
• Adverse Event management, tracking, and follow-up
• Data entry to CRF/EDC and query resolution in a timely manner
• Support study close-out, including COVs
• Protocol deviation tracking, reporting, and reconciliation
• Use and help improve Topography’s proprietary tool set
• Understand and comply with regulations, policies, and guidelines applicable to clinical research, including SOPs
• Assist in Quality Control activities including routine QC checks during and following study visits
• Any other duties assigned by manager

Clinical Research Coordinator

Job Level

Tech Stack

About the role

Requirements

Associate Director, Medical Writing

Mid-Level Clinical Site Identification and Start-Up Manager

Principal Quality Auditor – GCP

Senior Manager, Biostatistics

Clinical Research Associate - Boston, MA