Contributes to the selection of potential investigators.
In some countries, CRAs are accountable for study start-up and regulatory maintenance.
Trains, supports and advises Investigators and site staff in study-related matters, including Risk Based Quality Management (RbQM) principles.
Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training.
Ensures the sites are inspection ready at all times.
Actively participates in Local Study Team (LST) meetings.
Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
Updates CTMS and other systems with data from study sites as per required timelines.
Manages study supplies (ISF, etc), drug supplies and drug accountability at study site.
Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study-specific Monitoring Plan.

Requirements

Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
Must be bilingual in French and English
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 AZ 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.
Valid G driving license.

Benefits

Competitive Flex Benefits & Retirement Savings Program
4 weeks’ paid vacation
Annual Personal Days
Variable Pay Bonus/Short Term Incentive opportunity

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

ICH-GCPGMPGDPClinical Study ManagementRisk Based Quality Managementdata managementdrug development processmonitoringstudy drug handlingattention to detail

Soft Skills

bilingualwritten communicationverbal communicationcollaborationinterpersonal skillsnegotiation skillsproblem-solvingattention to detailability to traveltraining and support

Certifications

Bachelor degree in life sciencevalid G driving license