The Clinical division of Abbott Medical Devices in Belgium is looking for a Clinical Research Associate II .
Working with a moderate level of mentorship and direction, you assist in the planning and conduct of clinical studies.
As a CRA II, you will ensure that all assigned clinical projects align with both regulatory and clinical protocol compliance.
Your responsibilities include assisting in the development of study related materials as well as writing sections of the protocol summary, annual report and other study reports.
You will also be involved in the creation and review of informed consent document to ensure all required elements are included.
You assist with site nomination, qualification, and selection processes.
Your tasks also include:
- Reviewing and analyzing data and documents for accuracy and completeness.
- 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 possible.
- Drafting Serious Adverse Event narratives
- Serving as a liaison to clinical study management, field clinical personnel and site personnel by responding to any protocol-related issues and raising 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 more junior 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
- Strong written and verbal communication, presentation, analytical skills
- Ability to interpret basic clinical data, to meet deadlines and to communicate effectively.
- Familiarity with Microsoft Word, Excel and Outlook programs and clinical applications
- Ability to work independently when necessary
Are you the Clinical Research Associate we are looking for? Please apply online.