Clinical Research Associate (CRA) (d/f/m)

The Clinical Research Associate executes internal and external clinical study related activities to effectively run clinical projects from initiation to close-out within agreed time frame.

Key Responsibilities

• Perform all clinical site monitoring activities, inclusive of all study visit types (SQV, SIV, IMV, CDV)
• Participate in the clinical site selection process
• Contribute to the development of study documents, tools and materials, as well as other documentation for conducting clinical studies
• Submit clinical studies to ethical committees and competent authorities
• Conduct and/or support centralised monitoring activities
• Maintain adherence of clinical sites to agreed recruitment plan, timetable, and quality specification
• Monitor study progress closely to anticipate and identify issues; resolve study related issues (e.g., enrolment speed, protocol deviations, serious adverse events, detected deficiencies, corrective actions, etc.), and escalate as necessary
• Maintain or manage the study Trial Master File (TMF), Clinical Trial Management System (CTMS) and other project tracking tools
• Create spreadsheets, reports and/or presentation for project status reporting
• Administrative duties
• Perform other duties as assigned
• Day-to-day management of study to ensure compliance, data quality and adherence to timeline incl. site quality activities

Education

• Professional education or bachelor’s degree in a medical or scientific field; preferably optics. Familiar with GCP and ISO14155

Experience

• At least 2 years of experience as a CRA in clinical study management, or related field

• Experience in medical device industry and ophthalmology

Legally required qualification (e.g. “Medical device advisor”)

Skills

• Systematic and organized, pragmatic approach in problem solving; excellent interpersonal and written communication skills; compliance mindset; ophthalmological understanding/experience

• Proficient at database systems, eCRF (EDC) and Microsoft Office

Speak and write fluently in English, work within an international environment. Fluent in German is a plus

Travel Requirements

• High travel requirement (up to 3-4 days per week); driver’s license required and must be an active driver

Working Condition

• Standard office working condition; Remote/Field work; Domestic and International travel (car or public transport)