The Clinical Research Associate will perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and Standard Operating Procedures.
Main activities are:
Conduct site visits to assess protocol and regulatory compliance and manages required documentation
Serve as primary contact for investigators and study coordinators for study related questions and develop collaborative relationships with the sites
Assist and support development and review of clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Case Report Forms, Source Documents, Monitoring Plan, Data Management Plan, Project Management Plan, etc.).
Manage patient recruitment strategies to increase patient randomization into the trial (eg investigator and research nurse meetings, update newsletters, advertising, letters to GPs).
Review all AE/SAEs and ensure appropriate documentation is in place and any other safety issues are addressed and communicated.
Assist and support data validation and data cleaning procedures to ensure timelines are met.
Order and coordinate study supplies for clinical studies
Develop and maintain tracking tools to support management of clinical studies.
Plan and participate in Investigator meetings and CRA trainings.
Support feasibility and site selection process for clinical studies.
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Qualifications
Minimum of 2+ years of experience in the pharmaceutical / biotechnology / CRO industry monitoring as a Clinical Research Associate from study start-up to database lock.
Good knowledge of concepts of clinical research and drug development.
Strong working knowledge of EDC, IVR and CTMS systems.
Ability to handle and prioritize multiple studies and projects. Ability to work effectively in a team/matrix environment. Ability to understand technical, scientific and medical information.
Demonstrated strengths in planning, organizational, project management, analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills.
Enthousiastic to travel across the country and exceptionally abroad.
What we offer:
We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers , eco vouchers, mobile phone (data included)We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, ...)
Side activities will be organised regularly, to achieve a close collaboration within our team
We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
We contribute to a number of charities & support the research and / or the patients in our industry.