Abbott Clinical Research Associate II in Zaventem, Belgium
The Clinical division of Abbott Medical Devices in Belgium is looking for a CLINICAL RESEARCH ASSOCIATE II .
Working with a moderate level of guidance and direction, the CRA assists in the planning and conduct of clinical studies.
The Clinical Research Associate II will ensure both regulatory and clinical protocol compliance is maintained for all assigned clinical projects.
This may include but is not limited to :
Assisting in the development of study related materials such as: patient brochures, patient recruitment material, and presentations.
Assisting in writing sections of the protocol summary, annual report and other study reports.
Assisting in the development and review of informed consent document to ensure all required elements are included.
Assisting with site nomination, qualification, and selection processes.
In consultation with the assigned field clinical and appropriate in-house personnel, coordinating the start-up and maintenance of the clinical study site.
Coordinating activities with study specific committees, vendor services, and core labs.
Reviewing and analyzing data and documents for accuracy and completeness. Creating and processing data queries.
Assisting with preparation, follow-up, and resolution of findings from monitoring visits and audits.
Reviewing and processes product complaints and adverse events as soon as they are reported.
Drafting Serious Adverse Event narratives
Your tasks also include:
Serving as a liaison to clinical study management, field clinical personnel and site personnel by responding to any protocol-related issues and escalating as appropriate.
Communicating and collaborating with all levels of employees, customers, contractors and vendors.
Applying general clinical research processes and regulatory knowledge to process improvement activities.
Training internal and external clinical professionals to ensure compliance with established protocols.
Mentoring less experienced clinical team members.
Who are we looking for?
University graduate, preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field.
Minimum 2 years of clinical experience
Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to interpret basic clinical data, to meet deadlines as well as the ability to communicate effectively with all levels of employees.
Familiarity with Microsoft Word, Excel and Outlook programs and relevant clinical applications.
The ability to work independently when necessary.
The ability to exchange straightforward information, ask questions, and check for understanding.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com