For one of our clients, a Contract Research Organisation specialised in medical devices, we are looking for a CTA.
- Do you have a first experience as CTA or study coordinator?
- Do you have a hands on mentality, are you flexible and a multitasker?
- Do you speak English and Dutch or French?
Then this could be the job you are waiting for!
Under the direction of the Associate Director of Clinical Operations, the Clinical Trial Assistant has responsibility for assisting the project team with the comprehensive management of clinical studies and communication with study sites and sponsors. Occasional travel may be required.
- Assist with the coordination and management of assigned projects, with guidance from the Project Leader and/or Project Manager and with the assistance of other staff.
- Ensure that adherence to industry standards and regulatory requirements, including but not exclusive to contractual agreements, department guidelines, SOPs, applicable international, Federal and State regulations, and ICH Guidelines.
- Collaborate with clinical operations administration to identify and oversee trial-related training and any performance concerns of team members according to their individual needs.
- Assist in the development of study documents such as informed consent forms, monitoring templates, tracking tools and study manuals.
- Participate in the maintenance of clinical trial documents, processes and systems according to trial-specific scope of work and budget, and possess the skills.
- May participate in site selection and training of site personnel regarding the trial.
- Request, collect and review site start-up documents.
- Coordinate IRB/EC submissions and track progress to approval
- Track study site activities, including but not limited to:
- Screening and enrollment
- Collection and review of site essential documents for completeness
- Trial Master File Maintenance
- Study site progress and issues
- Attend project meetings; participate in internal meetings as scheduled.
- Perform related duties as required and assigned.
- Knowledge of medical terminology, Federal regulations and ICH-GCP, time management and problem solving skills, and the research process.
- Must be able to work independently following a brief period of specific job related training.
- Must possess excellent verbal and written communication skills.
- Strong organizational skills with attention to detail.
- Must demonstrate basic computer proficiency.
- Demonstrate a high degree of personal and professional integrity.
- A bachelor/master degree
015 21 11 04