Clinical Research Associate I(m/w/x)

Beschreibung

You will drive clinical trial success by managing site activities and ensuring strict regulatory compliance. From site initiation to closure, you'll maintain data quality and protect subject safety.

Anforderungen

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

Aufgaben

• •Organize and manage in-house clinical projects
• •Ensure compliance with GCP and SOPs
• •Support study startup and site opening
• •Manage clinical investigative site activities
• •Monitor data quality and submission timelines
• •Report and follow up on safety events
• •Ensure safety and protection of study subjects
• •Conduct site qualification and monitoring visits
• •Perform study closeout and site closure tasks
• •Train site personnel on regulatory requirements
• •Escalate serious or outstanding project issues
• •Facilitate quality assurance audit processes
• •Maintain regulatory inspection readiness at sites
• •Prepare accurate monitoring and administrative reports
• •Provide periodic study progress updates to management
• •Support clinical trial application submissions
• •Manage informed consent changes and translations
• •Perform remote monitoring activities as required
• •Assist in study budget and agreement preparation
• •Negotiate investigator and hospital agreements
• •Process payments according to executed contracts
• •Complete and maintain personal expense reports
• •Implement innovative processes to improve efficiency

Tools & Technologien

Benefits