Site-icra Ii

il y a 1 semaine

Zaventem, Belgique Abbott Laboratories Temps plein

The Clinical division of Abbott Medical Devices in Belgium is looking for a ICRA II (**CLINICAL RESEARCH ASSOCIATE II**).

The ICRA II participates in the planning and execution of Abbott clinical studies at the assigned study sites.

**Your Responsibilities**:

- Supports regulatory and clinical protocol compliance for all assigned clinical projects at the assigned study sites.
- In partnership with the assigned Abbott field staff and in-house personnel, coordinates the startup, maintenance and close out of the assigned clinical study sites.
- Acts as primary contact for the assigned study sites.
- May review informed consent documents to ensure all required elements are included.
- Reviews and analyzes study data, regulatory documents for accuracy and completeness, supports data query resolution
- Supports the follow-up and resolution of findings from monitoring visits and audits on the assigned study sites.
- Serves as a liaison to clinical study management, site management personnel and site personnel by responding to any protocol-related issues and escalating as appropriate.
- Communicates and collaborates with all levels of employees, customers, contractors, vendors and study sites.
- Applies general clinical research processes and regulatory knowledge to process improvement activities.
- Supports training of internal and external clinical professionals to ensure compliance with established protocols and/or internal processes.
- Updates and maintains internal clinical trial information and document management systems.
- Collects and maintains regional and study site specific communication to facilitate activation and execution of clinical studies at assigned study sites.
- Mentors less experienced clinical team members.
- This position may require up to approximately 50 % travel.

**Your Profile**:

- Bachelor’s degree preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering with a minimum of 3 years clinical research experience, or an equivalent combination of education and experience.
- 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.

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