In-house CRA

Jobinhalt

iSTAR Medical SA, founded in 2011 and headquartered in Wavre, Belgium, is a medical technology company focused on the development of MINIject®. MINIject® is a minimally invasive glaucoma surgery (MIGS) device for patients with glaucoma. Glaucoma is the second leading cause of adult blindness globally and the leading cause of irreversible blindness. Our mission is to become the world leader in minimally invasive implants for glaucoma surgery.

Reporting to the Clinical Manager, the In-house CRA will support Clinical Team in managing international clinical studies.

Responsibilities:

• Provide inputs to specific study-related documents(Project Plan, Monitoring Plan, Data Review Plan, Manual of Operations, logs and templates, clinical study report);
• Participate in Trial Site Selection as needed(evaluation of sites, due diligence,…);
• Participate in Competent Authorities and Ethical Committee submission as needed(develop documents, translations, track submission timelines, answer questions,…)
• Coordinate Set-up Trial Activities(site initiation, training, recruitment planning);
• Coordinate Investigational Device and Supplies shipment to Trial Site
• Coordinate Monitoring activities(monitoring visits, remote monitoring activities, site management, essential documents collection);
• Monitor study progress at study sites
• Ensure compliance with guidelines, protocols and work instructions by maintaining regular interaction with study sites
• Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the standard operating procedures
• Conduct periodic review of data quality. Identify, communicate, and find resolutions for all issues during the trial
• Participate in e-CRF design and data base development
• Perform remote data review and cleaning according to the data review plan
• Coordinate Reading Center activities
• Coordinate Close-out activities
• Support quality control & assurance activities(Internal QC, CRO & study site audit,…)
• Ensure study conduct is performed according to Good Clinical Practices and applicable regulations

As the successful candidate, you have the following profile:

• You own a Master’s degree in Life Sciences. Knowledge in ophthalmology is beneficial
• You have at least 3 years of demonstrated experience in clinical study research and/or in biotechnology or related industry
• You have a solid knowledge of Good Clinical Practices
• You are thorough and pay attention to detail
• You can communicate effectively; set priorities and you have time management skills
• You are fluent in English, written and spoken. Knowledge of another language is beneficial
• You are able to use a computer and the main software packages competently
• You are a team player with positive constructive attitude to solve problems
• You are eager to learn, stress resistant and ready to work independently in a start-up environment (hands on)

What we offer?

• We offer a full-time permanent position along with an attractive remuneration package.
• The position is based in Belgium (Wavre) with possibility to work from home a few days a week and has an international scope.
• Headed by a solid management team, you will be part of a highly skilled (engineers, scientists) capable and dynamic team of innovative leaders with proven tracks records in the pharmaceutical and medical device industries.
• We have an agile start-up company culture focused on values of entrepreneurship, engagement, integrity, passion and excellence.