We are actively looking for inhouse CRA's for one of our clients. Our client is a sponsor with an innovative pipeline. You will be part of an international team.
- Do you have previous clinical research experience, or experience with data review, EDC, site start-up, site contact?
- Can you work independently, pro-active, and do you learn easily?
- Are you fluent in English?
Then this might be the perfect position for you, find out more below!
As an Inhouse CRA you play a crucial part in the smooth conduct of the Clinical research process.
Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects. This may include but is not limited to :
- Assists in the development of study related materials such as: patient brochures, patient recruitment material, and presentations.
- Assists in writing sections of the protocol summary, annual report and other study reports.
- Assists in the development and review of informed consent document to ensure all required elements are included.
- Assists with site nomination, qualification, and selection processes.
- In consultation with the assigned field clinical and appropriate in-house personnel, coordinates the start-up and maintenance of the clinical study site.
- Coordinates activities with study specific committees, vendor services, and core labs.
- Reviews and analyzes data and documents for accuracy and completeness. Creates and processes data queries.
- Assists with preparation, follow-up, and resolution of findings from monitoring visits and audits.
- Reviews and processes product complaints and adverse events as soon as they are reported.
- Drafts Serious Adverse Event narratives
Serves as a liaison to clinical study management, field clinical personnel and site personnel by responding to any protocol-related issues and escalating as appropriate.
- Ensures the clinical study site adheres to the assigned protocol and all applicable regulatory standards. Notify appropriate study management when concerns exit.
- A Bachelor degree from an accredited university or college. Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field.
- Minimum 1 year of clinical research experience (for example as a Data Manager, Study Coordinator, CRA, ...)
- A general familiarity with clinical trials research processes. Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment.
- Must have demonstrated strong written and verbal communication in English, any other European language is a plus.
- Next, you have strong interpersonal, presentation, analytical, and the ability to interpret basic clinical data,
- You are able to meet deadlines and have good organizational skills
- Familiarity with Microsoft Word, Excel and Outlook programs and relevant clinical applications.
- The ability to work independently when necessary.
- The ability to exchange straightforward information, ask questions, and check for understanding.
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