Description:
Job Title: Freelance CRA

Location: Belgium

Schedule: Home-based

TalentSource Life Sciences is currently searching for an experienced freelance Clinical Research Associate (CRA) to be outsourced to one of our partner pharmaceutical companies in Belgium. This position will be for 0.25 - 0.35 FTE.

The successful candidate will be working on studies dedicated to one client . As a client-facing role, we are looking for confident candidates with strong site management skills and the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager who will work closely with you to support your professional development and growth.

Position Duties & 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, 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)
• Contribute to the organisation of, and the participation in, investigator meetings

Education & Qualifications

• BSc in Life Science or equivalent

Experience, Skills, Knowledge

• Previous monitoring experience is essential
• Experience in Regulatory Submissions
• Up to date knowledge of ICH/GCP
• Ability to learn and apply SOPs and other current regulations
• Excellent knowledge of clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirements
• Fluent in English
• Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
• Willingness to travel 25% of the time

If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002068

If you would like to discuss the role before applying through the website, please contact Alessandra.Bolognani@cromsource.com for more information.

Why choose TalentSource Life Sciences/CROMSOURCE?

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsorled team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our clientfacing positions, you must be confident, be able to drive the role and work autonomously.

CROMSOURCE is an independent, international Contract Research Organisation (CRO) operating in over 40 Countries and 16 offices with approximately 500 professional team members, making it one of the largest independent CROs in Europe. Our international headquarters located in Verona, Italy and Waltham, USA and with local offices in Belgium, The Netherlands, Germany, Poland, Russia, Spain, Switzerland and the United Kingdom.

Our key approach is to equally value our clients and our own people. Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highlyqualified personnel through our dedicated training team, focused on employee development. We also understand the importance of a good worklife balance and we offer flexible solutions for a high number of positions.

The success of these core values are evidenced by our below industry average turnover rates.

By joining our teams, you can be part of making a difference in the lives of people and experience a fulfilling and rewarding career. Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world.

CROMSOURCE is an equal opportunity 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.

How can we help you on your next career move? Learn more on LinkedIn, Pharmiweb, Facebook, Twitter, and Glassdoor.

Keywords: Freelance Clinical Research Associate, Freelance CRA

Skills: Clinical Research Associate Location: Belgium Share:

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