In this role you will be working in with our in-house team. You will be responsible for full site management from feasibility to close out of studies. We have a varied client base, ranging from small-mid sized Pharma and Medical Device companies. Monitoring required at the following sites in Croningen, Leiden and Radboud Main Job Tasks and Responsibilities
Education and Experience
- Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the investigation sites
- Performs training of site staff in all study procedures in order to ensure protocol/ICHGCP compliance
- Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness and quality of Case Report Form (CRF) in compliance with the protocol, SOP's and ICH-GCP requirements in order to ensure data integrity and subject safety
- Adapts and translates Patient Information Leaflets and Informed Consent Forms
- Cooperates with the site staff for ensuring a proper reporting from the site of the safety issues (adverse events and adverse reaction such as AEs/SAEs, SUSARs, etc.) and their follow up, guaranteeing timely and appropriate handling of safety issues
- Escalates any issues to relevant project team members
- May assist in contract negotiation with sites on study budget after appropriate and documented training
- May support the submission process in the project (or region)
Who will you be working for? About CROMSOURCE:
- You have a University Degree in scientific medical or paramedical discipline
- Prior experience as a CRA
- Excellent knowledge of clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirement
- Fluent in English
- Proficiency in Microsoft Office (e.g. Word, Excel, Outlook
- Willingness to travel
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do. Our Company Ethos:
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.
The Application Process: If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002293 or contact firstname.lastname@example.org for more information.
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
CRA, Clinical Research Associate, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, submissions, Clinical Research ICH-GCP, Monitoring, Home based
Skills: Freelance, Senior Clinical Research Associate Location: Netherlands Share:
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