For a pharmaceutical company, we are looking for a Study Start-up CRA. Our client is very flexible with respect to working hours and homebased working. If you don't want to be on the road all the time but still like to have a crucial role in clinical trials, this is the job for you!
- Do you have experience in site monitoring, as study co-ordinator and/or with study start-up activities
- Are you fluent in English with a good knowledge of Dutch and French
- Do you want to expand your project management skills via study oversight activities
Then this is the step in your career that you have been waiting for!
As a Study Start-up CRA you will be managing and overseeing all Study Start-Up related activities, in collaboration with the involved clinical research stakeholders. Next, you are responsible for clinical trial oversight activities.
- You execute all start-up activities prior to site activation on the assigned studies
- You coordinate protocol and site level feasibility activities, including evaluation of patient population and final site selection
- You provide clinical trial oversight to the local study teams
- You coordinate the operational aspects for implementation of the clinical trial activities
- You are involved in the negotiation of site budgets, budget plans and you provide oversight for site payments
- You manage the communication with local study teams and to sites as required
- You give support in the management of country-level Trial Master File (TMF) and reviews for quality (including translations, as applicable).
- You update regulatory requirements, ensure adherence and compliance with local regulations and internal procedures.
- You are responsible for the preparation of Informed Consent Forms (ICF) and obtain ethics committees' and local regulatory authorities' approval. You prepare ongoing submissions, amendments and periodic notifications.
- You are the liaison for communications with relevant authorities/bodies to further enhance the clinical trial process
- You submit, according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions (SUSAR)
- You provide feedback to local vendor managers and CRA's
- You are responsible for the coordination of local affiliate study level audits and inspection audit action plan activities.
- University degree in a scientifical field or equivalent by professional qualification
- Demonstrated knowledge and understanding of clinical trials (study start-up + CRA/studyco experience ) and experience in managing projects
- A strong understanding of Good Clinical Practices (ICH-GCP), as well as an understanding of the regulatory, ethics and contractual requirements for starting clinical trials in relevant countries.
- Very good language skills (English, Dutch, French)
- Excellent communication skills
- High work standards, strong decision-making skills and able to adapt to varying conditions
015 21 11 04