Beschreibung

As an Assistant CRA, you will play a vital role in supporting clinical studies by collaborating with various teams, managing site logistics, and ensuring compliance with regulatory requirements. Daily tasks will involve training, document management, and facilitating communication between site staff and vendors.

Anforderungen

• •Bachelor's degree or equivalent
• •0 to 2 years of relevant experience
• •Basic medical/therapeutic area knowledge
• •Working knowledge of ICH GCP and applicable regulations
• •Effective oral and written communication skills
• •Excellent interpersonal and customer service skills
• •Good organizational and time management skills
• •Proven flexibility and adaptability
• •Ability to work in a team or independently
• •Well-developed critical thinking skills
• •Proficient computer skills with MS Office knowledge
• •Ability to extract information from study documents
• •German and English skills are mandatory
• •Proficiency in Italian or French is required

Aufgaben

• •Support execution of clinical studies
• •Collaborate with Remote CRA, On-Site CRA, and Study CTM
• •Contribute to site preparedness
• •Provide logistical and operational support during monitoring
• •Assist with site management and remote monitoring tasks
• •Complete and document study-specific training
• •Orient and train on CRG/study-specific systems
• •Provide in-house support during pre-study assessments
• •Customize Site ICF with site contact details
• •Perform remote review of EMR/EHR checklist
• •Verify document collection and RCR submission status
• •Update site EDL and verify site information
• •Review patient-facing materials and translations
• •Support site staff with vendor qualification process
• •Ensure system access for site staff is managed
• •Follow up on site staff training
• •Coordinate logistics for IM attendance
• •Maintain vendor trackers
• •Manage study/site supply during pre-activation
• •Complete assigned site management tasks
• •Maintain administrative tasks like expense reports
• •Support Essential Document collection and review
• •Follow up on missing study vendor data
• •Support ongoing remote review of monitoring tools
• •Coordinate site payments with functional departments
• •Perform reconciliation tasks on assigned trials
• •Verify document collection status in CRG systems
• •Drive action for missing or incomplete documents

Tools & Technologien