Clinical Research Associate
WHAT ARE YOUR MAIN RESPONSIBILITIES?
The Clinical Research Associate is responsible for site management related to clinical trials in different phases and therapeutic areas, ensuring that milestones, timelines and quality of such trials, as outlined by the study protocols, monitoring plans, SOPs, and applicable regulations and policies are met.
- Initiates, monitors and closes study sites in compliance with procedural documents and taking into account the quality standards and timelines. Shares information on patient recruitment, study site progress and escalates any issues to the study team
- Ensures that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements
- Obtains and updates essential documentation in compliance with ISO/GCP, Procedural Documents and local regulations
- Trains, supports and advises investigators and site staff about study-related matters in order to ensure compliance
- Is in charge of performance at the site. Proactively identifies study-related issues and finds the appropriate solutions independently or in cooperation with the study team lead
- 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 ISO/GCP requirements in order to ensure data integrity and subject safety
- Carries out source data verification (SDV) according to the monitoring or SDV plan.
- Ensures data query resolution.
- Prepares monitoring reports and confirmation / follow-up letters in a timely manner
- Manages study supplies and track the device/drug accountability at the study sites
- Cooperates with the site staff for ensuring a proper reporting from the site of the safety events (adverse events and adverse reaction such as AEs/SAEs, SUSARs, etc.) and their follow up, guaranteeing timely and appropriate handling of safety issues
- Actively participates in project team meetings
- Prepares activities related to audits and regulatory inspections together with the Project Leader and/or Project Manager • May interact with vendors, as required • Uses discretion, diplomacy and tact to resolve difficult situations. Escalates serious issues to management.
- Participates in the development and coaching of less experienced CRAs
WHAT DO YOU HAVE TO OFFER?
- Master degree in biological or (para-) medical sciences or equivalent by experience
- Minimum of 2 years’ experience in clinical research or equivalent by education or relevant experience
- Strong experience using Microsoft applications (Excel, Word, PowerPoint, Outlook)
- Excellent oral and written communications skills
- Excellent interpersonal skills
- Team player
- Demonstrates ability to make timely and well-reasoned decisions
- Demonstrates ability to effectively and persuasively communicate verbally and in writing
- Demonstrates ability to identify and adapt to shifting priorities and competing demands
- Ability to maintain composure in difficult circumstances
- Sensitive to cultural differences.
- Fluent in Dutch, French and English. Other language are a plus.
WHAT DOES TRIUM, part of the QbD group, OFFER YOU?
We are a healthy company with a strong growth and international ambitions. In addition to an attractive salary package, we can offer you the following advantages:
- We've got your back, giving you the opportunity to shape your career.
- Thanks to our flat organization, we have short communication lines and you can always come to us.
- Standing still means going backwards. With our extensive training package and our periodic knowledge-sharing moments, we offer you many opportunities to continuously learn, to expand or specialize your knowledge and skills and to gain new expertise.
- Get to know your colleagues outside the work environment! Teambuilding and fun activities are planned on a regular basis. A comedy night or quiz night? Nothing is too crazy for us!
- In short… We stand for JPEG: Joy in Partnership, going for the Extra mile to Get things done!
Interested? Send us your CV and motivation letter (both in English) and who knows, we might welcome you soon in our QbD group!