Location: Spain - home based (rolling, unit-based contract)
Schedule: Freelance - 0.3 - 0.5 FTE
CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Clinical Research Associate (CRA). You will be working on projects from our varied client base, ranging from small to mid-sized pharma, biotech and medical device companies. You will likely work on three studies likely within the Oncology, Back Pain and Paediatric HIV areas, with between 6 - 8 sites assigned.
Join our team and help us deliver clinical trials that will improve patients' lives.
Main Job Tasks and Responsibilities:
- 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, eligibility, 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)
Education and Experience:
- University Degree in scientific medical or paramedical discipline
- Prior experience as a CRA and site management
- Excellent knowledge of clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirement
- Fluent in English and local language
- Proficiency in Microsoft Office (e.g., Word, Excel, Outlook
- Willingness to travel
The Application Process
Once you have submitted your CV, you will receive an acknowledgement email. If you have the requirements we need, you will be invited for phone interview as the first step.
Who will you be working for?
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.
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.
Key words: CRA, Clinical Research Associate, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, submissions, Clinical Research ICH-GCP, Monitoring, Home based, Spain, Espana, Freelance, Freelancer, Contractor
Clinical Research Associate, Freelance, Senior Clinical Research Associate