Senior CRA I/II(m/w/x)

Deine Aufgaben

• •Perform and coordinate clinical monitoring and site management
• •Conduct remote or on-site visits to assess compliance
• •Manage required documentation for clinical trials
• •Ensure trials adhere to approved protocols and regulations
• •Maintain audit readiness at all times
• •Develop collaborative relationships with investigational sites
• •Monitor investigator sites using a risk-based approach
• •Apply root cause analysis to identify and resolve site issues
• •Ensure data accuracy through review of SDR, SDV, and CRF
• •Assess investigational products through inventory and records review
• •Document observations in reports and letters promptly
• •Communicate deficiencies and issues to clinical management quickly
• •Maintain regular contact with investigative sites between visits
• •Conduct monitoring tasks per the approved monitoring plan
• •Participate in the investigator payment process
• •Collaborate with project team on issue resolution
• •Investigate and follow up on findings as necessary
• •Provide trial status updates to the Clinical Team Manager
• •Update study systems according to study conventions
• •Perform quality checks on reports from the CTMS
• •Participate in investigator meetings as needed
• •Identify potential investigators in collaboration with clients
• •Initiate clinical trial sites to ensure compliance
• •Ensure trial closeout and retrieval of trial materials
• •Verify essential documents are complete and compliant
• •Conduct on-site file reviews as specified
• •Assist in preparing project publications and tools
• •Facilitate communication between sites, clients, and project teams
• •Respond to regulatory requirements and audits
• •Complete administrative tasks like expense reports and timesheets
• •Contribute to process improvement initiatives as required