Beschreibung

As an Assistant CRA, you will engage in remote site management, ensuring compliance with regulations while collaborating closely with site staff. Your role involves monitoring study performance, conducting evaluations, and providing essential training to maintain high standards in clinical trials.

Anforderungen

• •Bachelor’s Degree in life science-related field
• •Prior clinical research experience 0-1 year
• •Aspiration to advance into CRA role
• •Basic medical/therapeutic area knowledge
• •Knowledge of ICH GCPs and applicable regulations
• •Ability to complete PPD’s Clinical Foundation Training Program
• •Ability to complete RSM Onboarding Workshop
• •Fluency in German and English (minimum C1 Level)
• •Ability to evaluate medical research data
• •Ability to advise and motivate investigational sites
• •Effective oral and written communication skills
• •Excellent interpersonal and customer service skills
• •Good organizational and time management skills
• •Proven flexibility and adaptability
• •Strong attention to detail
• •Ability to work in a team or independently
• •Well-developed critical thinking skills
• •Ability to coach and mentor site personnel
• •Good computer skills and knowledge of MS Office
• •Ability to extract information from study documents

Aufgaben

• •Perform remote site management and monitoring activities
• •Develop and maintain collaborative communication with site staff
• •Discuss protocol conduction and enrollment strategies
• •Track and follow up on subject data in EDC and other systems
• •Raise manual queries in EDC when necessary
• •Review study logs remotely as needed
• •Conduct and document site management calls according to the monitoring plan
• •Participate in investigator meetings
• •Investigate and follow up on centralized monitoring findings
• •Evaluate PI oversight and subject safety regularly
• •Conduct remote investigations into site performance
• •Apply root cause analysis to identify site process failures
• •Provide refresher training and follow up on administrative needs
• •Assist with regulatory reviews as requested
• •Review ad-hoc clinical listings and track violations
• •Provide trial status tracking and progress updates to the study manager
• •Participate in the investigator payment process if applicable
• •Liaise with internal staff to collect documents and review data
• •Ensure audit-ready files and compliance with CTMS and eTMF
• •Contribute to regulatory requirements and audit responses

Tools & Technologien

Benefits