Contributes to the selection of potential investigators
Responsible for study start-up and regulatory maintenance when required
Trains, supports and advises Investigators and site staff in study related matters
Confirms that site staff complete required trainings, including ICH-GCP training
Actively participates in Local Study Team (LST) meetings
Initiates, monitors and closes study sites in compliance with client’s Procedural Documents
Drives performance at the sites and resolves study-related issues
Updates CTMS and other systems with data from study sites
Manages study supplies and drug accountability at study sites
Performs monitoring visits, remote data checks, and Source Data Review, CRF review, and Source Data Verification
Ensures data query resolution in a timely manner
Works with data management to ensure quality of collected study data
Ensures accurate and timely reporting of Serious Adverse Events and their follow ups
Prepares monitoring visit reports in CTMS and provides feedback to Principal Investigator
Follows up on outstanding actions with study sites

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.

Senior Clinical Research Associate

Key skills