Contributes to the selection of potential investigators
In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance
Trains, supports, and advises Investigators and site staff in study related matters
Ensures the sites are inspection ready at all times
Actively participates in Local Study Team (LST) meetings
Drives performance at the sites
Updates CTMS and other systems with data from study sites as per required timelines
Performs monitoring visits (remote and onsite)
Ensures data query resolution in a timely manner
Supports/participates in regular QC checks performed by LSAD or delegate
Ensures compliance with client ’s Code of Ethics, company policies and procedures

Bachelor degree in related discipline, preferably in life science, or equivalent qualification
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
Good knowledge of relevant local regulations
Good medical knowledge and ability to learn relevant client’s Therapeutic Areas
Basic understanding of the drug development process
Good understanding of Clinical Study Management including monitoring, study drug handling and data management
Excellent attention to details
Good written and verbal communication skills
Good collaboration and interpersonal skills
Good negotiation skills
Ability to travel nationally/internationally as Required

Clinical Research Associate – FSP

Key skills