Clinical Research Associate I(m/w/x)

Description

You will play a vital role in managing clinical trials by overseeing site activities and ensuring regulatory compliance. Your day-to-day involves everything from site monitoring to budget negotiation.

Requirements

• •Life-science, healthcare qualification, or equivalent experience
• •One year clinically-related experience preferred
• •Knowledge of therapeutic indications preferred
• •Knowledge of industry-sponsored clinical research preferred
• •Knowledge of ICH/GCP Guidelines preferred
• •Strong planning and organizational skills
• •Ability to follow work processes
• •Strong analytical and conceptual capabilities
• •Clear communication and interpersonal skills
• •Ability to address clinical site issues
• •Demonstrated business ethics and integrity

Tasks

• •Organize and manage in-house clinical projects
• •Ensure compliance with GCP and ICH guidelines
• •Participate in study startup and site opening
• •Manage clinical investigative sites across multiple protocols
• •Monitor data quality and submission timelines
• •Report and follow up on safety events
• •Ensure the safety and protection of subjects
• •Conduct site qualification and initiation visits
• •Perform interim monitoring and study closeout visits
• •Train site personnel on protocols and regulations
• •Escalate serious or outstanding project issues
• •Facilitate quality assurance audits and inspection readiness
• •Prepare accurate monitoring and administrative reports
• •Provide periodic study progress updates to management
• •Support clinical trial applications and document translations
• •Assist in study budget and agreement execution
• •Negotiate investigator and hospital agreements
• •Process payments according to executed agreements
• •Maintain personal expense reports per guidelines
• •Implement innovative processes to improve efficiency

Tools & Technologies

Benefits