Description:
Senior Clinical Research Associate (CRA)

Location: The Netherlands (Oost area) - Freelance - Part Time - Homebased

TalentSource Life Sciences is searching for an experienced freelance Senior Clinical Research Associate in The Netherlands to conduct oversight and monitoring activities for one of our clients.

The successful candidate will monitor clinical studies and assure high quality of the clinical data and perform regulatory activities.

Responsibilities:

• Conducts and reports periodic monitoring visits (2 remotely and 1 actual visit) 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.
• Conducts source data verification and in house review of clinical data and ensuring timely resolution of data queries to guarantee reliable clinical data.
• 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.
• Conducts and reports study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project.
• Is the main contact person for the site in order to ensure close follow up.
• Reports to the Sponsor's Project Manager on all activities performed during the study and sends all relevant documents according to the timelines and the requirements agreed.

Qualifications:

• University Degree in scientific, medical or paramedical degree
• Five (5) years (at least) of experience as a CRA
• Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
• Fluent in English and local language(s)
• Ability to problem solve
• Good communication to successfully manage the sites
• Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
• Willingness to travel

If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001847

If you would like to discuss the role before applying through the website, please contact alexander.sourounis@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 sponsor-led 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 client-facing 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 highly-qualified personnel through our dedicated training team, focused on employee development. We also understand the importance of a good work-life 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: Senior Clinical Research Associate, Clinical Research Associate, SCRA, CRA, Clinical, Monitor, GCP, Freelance, Part time, CRO, Contract Research Organisation, Pharma
Skills: Clinical Research Associate, Senior Clinical Research Associate, GCP, Clinical, CRO, Monitoring Location: Netherlands