To bring clinical innovation into evidence-based medicine and reimbursement tracks, clinical research is key. As Clinical Research Coordinator, you will outline the clinical research strategy for Oncomfort together with the Chief Scientific Officer, coordinate the implementation towards internal and external stakeholders and manage the clinical research both on timing and budget.
You will directly report to the Chief Scientific Officer.
We offer you to be part of an exciting innovation in healthcare with a competitive result-driven package and the opportunities to grow with a great team.
Your main duties and responsibilities are to:
- Represent the company in clinical investigations and research-related partnerships.
- Define, organise and/or coordinate all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
- Support and/or organise recruitment of potential investigators, data-analysts, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organisation of meetings and other tasks as assigned by Chief Scientific Officer.
- Negotiate study budgets with potential investigators and assist the legal department with statements of agreements as assigned.
- Complete Serious Adverse Event (SAE) reporting, production of reports, narratives and follow-up of SAEs.
- Independently perform CRF review; query generation and resolution against established data.
- Development of clinical, application or other support material.
- Managing validation of Oncomfort clinical modules.
- Study team coordination, training of study sites and users or license owners.
- Assess patient recruitment and retention.
- Ensure that all aspects of designated clinical protocol are in accordance with project timelines, budgets and performance quality.
- Interact with Project Managers, sponsors, and vendors on project-related issues.
- Support company research, product management, support and other services in turning clinical and research outcome into product specifications.
- Communication and reporting towards clients, CRO’s and team members.
- Quality control of delegated tasks related to the projects.
- Creation, development and completion of the required study documents.
You are a structured research-oriented person, holding a Master's degree in biology, chemistry or commercial engineering with experience in a clinical research organisation. Alternatively, you hold an associates degree in Nursing with experience in managing clinical trials with experience as CRO collaborator. You are CRC certified and have 2+ years experience in clinical research coordination in healthcare.
Your skills and competencies
Your main skills and competencies are related to organisation and coordination of clients and their institutes to deliver the research according to the protocols and timetables. These include:
- Analytical mindset.
- Eye for detail.
- Exceptional interpersonal skills.
- Outstanding written and verbal communication in English, French and Dutch.
- Excellent organisational and coordination skill.
- Willingness to continuously self-educate.
- Ability to manage multiple projects at a time.