CRA II

As a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence, dedicated to a single sponsor.  In this role, you will work on Rare disease and Cystic fibrosis trials, conducting site monitoring visits in Denmark and 1 site in Sweden.

What you will be doing:

• Obtain and maintain essential documentation in compliance with ICH-GCP, company Procedural Documents and local regulations both in the office and at site.
• Actively participate in local Study Delivery Team meetings.
• Contribute to the selection of potential investigators.
• Train, support and advise Investigators and site staff in study related matters.
• Contribute to national Investigators meetings.
• Initiate, monitor and close study sites in compliance with company Procedural Documents. Share information on patient recruitment and study site progress within local Study Delivery Team.
• Drive performance at the sites. Proactively identify study-related issues and escalates as appropriate.
• Update systems with data from centres as per required timelines.
• Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
• Perform source data verification according to SDV plan.
• Ensure data query resolution.
• Ensure accurate and timely reporting of Serious Adverse Events.
• Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and CA&A.
• Provide the required monitoring visit reports within required timelines.
• Work with data management to ensure quality of the study data.
• Ensure compliance with the company’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

Additional Responsibilities May Include

• Ensure completeness of the Study Master File and ensure essential documents are sent to R&D site.
• Ensure timely delivery of proper applications/documents for submission to Regulatory Authorities.
• Ensure timely customization and completion of the CSA for designated studies
• Design draft budget for designated studies according to fSMA requirements
• Track and manage agreed payments at study site level.
• Participate in training and mentoring of new members of the local Study Delivery Team ensuring compliance with ICH/GCP and company Procedural documents.
• Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
• Contribute to process improvements, knowledge transfer and best practice sharing.
• Actively share applicable information that may be relevant to Marketing & Sales and the MC Medical Department and in accordance with Corporate Ethical guidelines.

You will need:

• University degree in related discipline, preferably in life science, or equivalent
• Fluent knowledge of spoken and written Danish
• Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
• Good knowledge of relevant local
• Good medical knowledge in relevant company Therapeutic
• Basic understanding of the drug development
• Good understanding of Clinical Study Management including monitoring, study drug handling and data
• Ability to travel nationally 

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.