Performs and coordinates all aspects of the clinical monitoring and site management process
Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation
Manages procedures and guidelines from different sponsors and/or supervising environments
Ensures that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs
Develops collaborative relationships with investigational sites
Ensures data accuracy through SDR, SDV and CRF review
Documents observations in reports and letters in a timely manner
Escalates observed deficiencies and issues to clinical management expeditiously
Ensures study systems are updated per agreed study conventions
Participates in investigator meetings
Initiates clinical trial sites according to relevant procedures
Ensures trial close out and retrieval of trial materials
Contributes to the project team by assisting in preparation of project publications/tools

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor)
Effective clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
Well-developed critical thinking skills
Ability to manage Risk Based Monitoring concepts and processes
Effective oral and written communication skills
Ability to maintain customer focus
Strong attention to detail
Effective organizational and time management skills
Ability to remain flexible and adaptable in various scenarios
Good digital literacy
Good English language and grammar skills
Good presentation skills

Clinical Research Associate II

Key skills