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:

If you think you are the right match for the following opportunity, apply after reading the complete 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:

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