Clinical Research Associate, 60-100% (ID 2117)

Main Responsibilities

• Manage clinical studies under scientific and legal guidelines, in collaboration with the project leader
• Prepare, conduct and follow-up on site evaluation , site initiation, site monitoring, and site close-out of the involved clinics (on-site and remote)
• Assures adherence to GCP, investigator integrity and compliance with all study procedures through the monitoring phase
• Make short and long-term plans to monitor involved clinics to ensure data quality and compliance
• Prepare, develop, and submit documents for public authorities and/or ethics commission submissions
• Develop and adapt Case Report Forms (CRFs)
• Control quality and collection of clinical data
• Update Project Managers regarding the documentation quality of the clinics and report regularly on the general status of the participating site
• Prepare and implement solutions, in collaboration with the project leader or Head Clinical Operations,to maintain or adapt the project timelines, budget and scope
• Maintain contact with Principal Investigators and Study Coordinators and provide them support to conduct the clinical investigation
• Conduct regular trainings for study sites to ensure data quality and regulatory compliance within the clinical investigation
• Prepare and develop Study Newsletters and annual reports as requested by the Project Manager Clinical Operations
• Prepare clinical data for analysis in collaboration with the project team, including Project Coordinator, Data Manager and Medical Statistician
• Assist in optimizing quality standards and SOPs
• Prepare, assist and coordinate contract negotiations
• The employee performs all tasks in alignment with the requirements of the ISO 9001 quality management standard and actively contributes to maintaining and improving the quality system
• The employee undertakes additional responsibilities and duties as assigned by the line manager to support operational and organizational needs related to the Quality Management System

Main Requirements

Core Skills/Competencies:

• Strong communication skills (written and verbal)
• Structured, detail-oriented working style and reliable documentation
• Ability to prioritize, manage multiple tasks, and meet deadlines
• Collaborative team player with a proactive, solution-oriented mindset
• Can perform assigned tasks independently using guidelines, regulations, and policies
• Supports the department in achieving its goals

Educational Requirements:

• Bachelor in Natural Science, nursing degree
• Further education in Clinical Research

 
Job Experience:

• Work experience as a Clinical Research Associate
• Good market and product knowledge
• Basic medical knowledge
• Good understanding of study-related outcome measures
• Experience with data capture in the field of clinical research
• Strong organizational and follow-up skills
• Attention to detail and reliability
• Ability to work both independently and in a team
• Flexibility and customer-focused mindset

Language Skills:

• Strong written and oral communication skills in English