We are searching for a Clinical Research Associate (HYBRID) for a TOP Medical Devices client based in Diegem, BE.
This individual will be responsible for managing clinical activities at study sites conducting studies for the Medical Devices group, as well as, fostering strong, productive relationships with colleagues within the Medical Devices Group.
The CRA is responsible for managing clinical study activities for multiple sites in single or several clinical projects. Oversees performance of appointed study sites, conducting company initiated clinical studies. Responsible for the site visits, monitoring, communication, and deliverables for the assigned study sites. Serves as a member of the clinical study team and is the liaison between the clinical study team and study site personnel for the specific clinical projects.
Clinical Study Site Management 95% / Other Administrative Activities 5%
- Clinical Study Site Management Tasks
- Ensures that all work related activities, and decisions embody the company values.
- Verify safety and well being of study subjects are maintained for assigned study sites.
- Support the operational execution of clinical trials and ensure collection of high quality, substantiated data.
- Execute clinical trials activities following established standard operating procedures, good clinical practices and regulatory requirements.
- Accountable for study site performance, and providing high quality data according to overall project timeline.
- Assist Clinical Operations staff and study site staff to quickly and effectively resolve issues. Responds to problems and assists in implementing corrective and preventive actions, if required.
- Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.
- Responsible for supporting patient recruitment and retention activities.
- Performs site visits and ensures study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies and procedures.
- Assists with internal communication of important clinical data and events.
- Functions as a reliable, trusted resource of accurate, up-to-date study site status knowledge, as requested by key stakeholders.
- Understand business value of clinical projects and balances overall business objectives and functional needs.
- Support the implementation of new clinical systems/processes.
- Interface and collaborate with Investigators, IRBs/ECs, contractors/vendors, and company personnel as needed.
- May be asked to provide additional support to Clinical Operations staff, as needed.
- A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science. At least 2 years of relevant experience; Masters or PhD/MD/PharmD with at least 1 year of relevant experience.
- Previous clinical research experience required.
- Previous medical device monitoring or equivalent experience is a plus.
- Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
- Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
- Clinical/medical background – a plus.
- Requires experience and knowledge working with computer systems (Microsoft Office – Excel, Word, and Power Point).
- Demonstrated competencies in Leadership, Written and verbal communications, Presentation and influencing, Strong organizational skills (e.g., able to manage multiple subprojects and tasks simultaneously and consistently meet all associated deadlines).
- Ability to travel up to 80% of time.
- Ability to read in English, French and Dutch preferred. Other languages (e.g. Italian, German) are a plus.
- Location: Diegem. On-site in Diegem once a week. Travel within Belgium 2-3 times per week.
- Duration: Initially 1 year contract with possibility for extension.\
- 40 hours per week
- Start date ASAP.
If Interested, please send your CV to Isla Littlewood at firstname.lastname@example.org or call +31 20 20 44 502 for more information.