Monitors the progress of clinical studies at investigational sites or at company headquarters and ensures they are conducted, documented and reported in accordance with the study protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and all applicable regulatory requirements.
Establishes and maintains collaborative relationships with investigators, Contract Research Organizations (CROs), affiliated hospitals and research institutions to initiate and advance clinical studies for investigational products or medical devices.
Responsible for the review of adverse events together with investigators, for planning and monitoring timelines, budgets and milestones, for preparing study-related documentation and for producing status reports.
May support the design, development and oversight of clinical evaluation projects where applicable.
Trains investigators and site staff.
Includes duties of Clinical Research Associates (CRA) performed both from a home office and in the field.
Implements and helps prepare the clinical development strategy defined by the clinical teams.
May contact qualified investigators and recommend them for study conduct and trial initiation.
Ensures recruitment and retention of study participants.

Bachelor’s, Master’s or diploma degree in natural sciences, nursing or another health-related field
Proven experience in clinical research monitoring
Good understanding of relevant regulatory requirements and standards (e.g., GCP, ICH guidelines, FDA CFR, ISO standards, clinical research ethics, EU directives, etc.)
Clear and effective verbal and written communication skills
Strong interpersonal skills and enjoyment of collaborative work
Proactivity and the ability to work in a fast-paced, changing environment
Ability to work in a matrix organization
Strong competencies and foundational skills in cross-functional collaboration, decision-making, execution, results orientation, process improvement and customer satisfaction
Ability to remain composed in challenging situations and to adapt to changing priorities and competing demands
High conscientiousness and attention to detail
Good problem-solving skills
Proficient with Word, PowerPoint, Excel and database applications
Business-level fluency in German and English

Associate Clinical Research Monitor, m/f/d

Key skills