This role involves the adept management of clinical activities at study sites within the medical devices domain. As a Clinical Research Associate (CRA), you will play a crucial role in overseeing and facilitating clinical studies.
Main activities are:
Manage clinical study activities across various sites for one or more clinical projects.
Oversee performance at appointed study sites conducting company-initiated clinical studies.
Conduct on-site visits to ensure adherence to study protocols, regulatory requirements, and internal policies.
Act as a liaison between the clinical study team and study site personnel.
Verify the safety and well-being of study subjects at assigned study sites.
Support the operational execution of clinical trials, ensuring collection of high-quality, substantiated data.
Follow established standard operating procedures, adhere to good clinical practices, and comply with regulatory requirements during the execution of clinical trial activities.
Accountable for study site performance and providing high-quality data within project timelines.
Contribute to the prompt resolution of issues, addressing problems, and implementing corrective and preventive actions as needed.
Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.
Support patient recruitment and retention activities.
Assist with internal communication of important clinical data and events.
Support the organization of Investigator and other study training meetings if required.
Support the implementation of new clinical systems/processes.
Collaborate with Investigators, Institutional Review Boards (IRBs)/Ethics Committees (ECs), contractors/vendors, and company personnel as required.
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Qualifications
Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
Minimum of 3 years of experience in a similar position within Clinical Operations
Previous medical device monitoring or equivalent experience required.
Previous experience in clinical research or equivalent is required.
Experience in neuro modulation or cardiovascular is an asset.
Relevant industry certifications preferred (i.e., GCP, ISO-14155, MDR, MEDDEV,…).
Experience and knowledge working with computer systems (Microsoft Office – Excel, Word, and PowerPoint).
Good written and oral English communication skills;
Demonstrated competencies in leadership, written and verbal communications, presentation and influencing, strong organizational skills.
What we offer:
We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers, eco vouchers, mobile phone (data included)
We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, ...)
Side activities will be organised regularly, to achieve a close collaboration within our team
We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
We contribute to a number of charities & support the research and / or the patients in our industry.