• Planning and coordinating of clinical trials at bioskin
• Clinical trial setup
• Generation of essential documents (trial protocols, subject information, regulatory documents)
• Clinical Trial Application to ethics committees and authorities
• Management of involved parties
• TMF maintenance
• Budget responsibility

Profile:

• Degree in a scientific or medical discipline
• At least 3 years of experience in the area of clinical trial management or clinical research, ideally multicenter and multinational trial experience
• Strong organziational and communication skills
• Well-structured and organized, target-oriented personality, team player
• Very good English skills
• Candidates with experiences in dermatology will be preferred

Contacts by headhunters, recruiting or staffing agencies are not accepted!

Please send your application including your anticipated salary to

• Performing and reporting site monitoring visits, including site selection, initiation, periodic and close out visits for clinical trials phase I-IV
• Ensuring adherence to international standards (e.g. ICH-GCP), standard operating procedures and clinical trial protocol
• Organizing investigator meetings together with the study team
• Maintaining investigator site files
• Assessing on-going training requirements of all sites staff and take appropriate action
• Identifying and escalating protocol deviations, discrepancies in data, and non-compliance to clinical trial protocols
• Working with different types of eCRF, CTMS systems
• Feasibility of sites
• Preselection visits, initiation visits, periodic monitoring and close out visits
• Collection of essential documents, review and maintenance
• Close cooperation with the different departments in-house at bioskin as well as vendors/freelance CRAs

Profile:

• Degree in a scientific or medical discipline or equivalent
• At least 3-5 years of experience as a Clinical Research Associate are imperative, ideally including multicenter and multinational trials
• Familiar with ICH-GCP guidelines, regulatory requirements, monitoring procedures and understanding of the clinical trial processes
• Experienced in medical device clinical trials and the applicable regulaotry requirements
• Well-structured and organized, target-oriented personality, team player
• Ability to thouroughly solve problems and issues
• Fluent in German and English (written and spoken)
• Ability and motivated to travel, including overnight stays
• Competent with MS Office applications
• Candidates with experiences in the indication dermatology will be preferred

Contacts by headhunters, recruiting or staffing agencies are not accepted!

Please send your complete application including your anticipated salary to

• Provides medical input during development of clinical trial protocols 
• Investigator in clinical trials, working according to clinical trial protocol, ICH-GCP and local regulations
• Attends to patients within the scope of clinical trials
• Performs physical exams, dermatological evaluation of skin disease severity, scoring of skin tolerability, sonographical and biophysical measurements 
• Evaluates lab and ECG reports
• Assesses any adverse events of investigative medicinal products
• Participates in study initiation and monitoring visits as well as sponsor audit visits 
• Contact for clinical team and sponsor regarding medical issues
• Performs medical monitoring over subject safety data