Clinical Research Associate

Take the next step in your clinical research career and contribute to high quality clinical studies within the medical device sector. We are looking for 2 profiles:

Like the look of this opportunity Make sure to apply fast, as a high volume of applications is expected Scroll down to read the complete job description.

• a Clinical Research Associate who combines strong site management skills with a solid understanding of clinical research regulations.
• a Senior Clinical Research Associate to take ownership of clinical site performance

Ready to grow your career and make real impact? Join MindCapture

We offer competitive salaries, a full benefits package (meal vouchers, eco vouchers, DKV health insurance, group insurance, net expense allowance and a company car). You also get the opportunity to shape your future through personalised training and development.

At MindCapture, you choose what you love, build on your strengths and make a difference where it matters most.

You will work as a MindCapture consultant for an international market leader in the healthcare industry.

Clinical Research Associate:

Job Description:

• Manage clinical study activities across multiple study sites and clinical projects
• Oversee site performance and ensure delivery of high quality clinical data within project timelines
• Conduct site visits and monitor compliance with study protocols, applicable regulations, policies and procedures
• Support the operational execution of clinical trials and the collection of substantiated clinical data
• Verify that study subject safety and wellbeing are maintained at assigned study sites
• Collaborate with clinical operations teams and study site staff to identify and resolve issues effectively
• Support corrective and preventive actions when required
• Verify that Investigator Site Files are maintained according to applicable regulations and procedures
• Support patient recruitment and retention activities
• Facilitate communication of important clinical data and study events to relevant stakeholders
• Support investigator meetings, study training activities and implementation of clinical systems and processes
• Collaborate with investigators, ethics committees, contractors, vendors and internal stakeholders

Requirements:

• Bachelor degree required, preferably in Life Sciences, Physical Sciences, Nursing or Biological Sciences
• At least two years of relevant experience with a Bachelor degree, or at least one year with a relevant advanced degree
• Previous clinical research experience required
• Previous medical device monitoring or equivalent experience required
• Strong understanding and practical application of clinical research regulations and standards for medical devices or combination products
• Relevant industry certification is preferred
• Clinical or medical background is preferred
• Experience with Microsoft Office including Excel, Word and PowerPoint
• Strong leadership, written communication, verbal communication, presentation and influencing skills
• Excellent organisational skills with the ability to manage multiple tasks simultaneously and consistently meet deadlines
• Ability to travel up to 80% of the time in Belgium
• Be able to converse and monitor in English and Dutch is required - French is preferred

Senior Clinical Research Associate

Job Description:

• Manage clinical study activities across multiple study sites and clinical projects
• Oversee assigned site performance and ensure delivery of high quality clinical data within project timelines
• Conduct site visits and monitor compliance with study protocols, applicable regulations, policies and procedures
• Support clinical trial execution while safeguarding study subject safety and wellbeing
• Ensure clinical activities follow applicable standard operating procedures, good clinical practices and regulatory requirements
• Work with clinical operations teams and study site staff to resolve issues and support corrective and preventive actions when required
• Verify that Investigator Site Files are maintained according to applicable regulations and procedures
• Support patient recruitment and retention activities
• Communicate important clinical data, study events and site status information to relevant stakeholders
• Support investigator meetings, study training activities and implementation of clinical systems and processes
• Collaborate with investigators, ethics committees, contractors, vendors and internal stakeholders

Requirements:

• Bachelor degree required, preferably in Life Sciences, Physical Sciences, Nursing or Biological Sciences
• At least four years of recent site monitorin