Sr. Clinical Research Associate - Belgium (French & Dutch Fluency)

Imagine a role where your daily work directly impacts the lives of patients battling challenging gastrointestinal diseases. At Alimentiv, that's not just a dream, it's our reality, and it could be yours too. We're on the hunt for a Senior Clinical Research Associate who thrives on making a genuine difference, someone ready to dive deep into clinical trials across Belgium. If you're passionate about advancing therapies and possess excellent fluency in both French and Dutch, this might just be the meaningful next step you've been searching for in your career. This is a chance to join a purpose-driven global team, working fully remotely from anywhere in the world, and truly contribute to something significant.

Overview

Alimentiv stands as a dedicated global Clinical Research Organization, committed solely to accelerating therapies for individuals facing gastrointestinal illnesses. For over three decades, our profound purpose has fueled our rigorous scientific approach, unwavering operational excellence, and specialized therapeutic knowledge. We proudly support more than 70% of inflammatory bowel disease compounds in development. As a private, 'profit-with-purpose' organization, we reinvest our commercial successes directly into groundbreaking scientific research, innovative technology, and our most valuable asset: our people. With nearly 700 professionals spread across various countries and three distinct service lines, our growth is intentional and our leadership's capability is central to our collective success. This Senior Clinical Research Associate position is a fully remote, worldwide opportunity where you will independently manage clinical site monitoring and site management activities across Belgium, acting as a crucial link between our organization and investigative sites from study start-up through close-out. You will ensure strict adherence to protocols, ICH-GCP guidelines, and regulatory requirements, playing a pivotal role in the successful delivery of our clinical trials.

Key Responsibilities

Oversee Clinical Site Monitoring: Independently manage and execute all aspects of clinical site monitoring visits, including pre-study, initiation, routine, and close-out visits in Belgium.
Site Management Expertise: Provide comprehensive site management activities, serving as the primary point of contact for investigative sites, fostering strong relationships, and ensuring effective communication.
Protocol and GCP Adherence: Ensure strict compliance with study protocols, Good Clinical Practice (ICH-GCP) guidelines, standard operating procedures (SOPs), and relevant regulatory requirements.
Data Integrity: Meticulously review source documents, electronic case report forms (eCRFs), and other study-related documentation to verify accuracy, completeness, and consistency of data.
Investigational Product Management: Monitor the accountability, storage, and reconciliation of investigational products at assigned sites.
Issue Resolution: Proactively identify, address, and resolve site-related issues, discrepancies, and challenges in a timely and professional manner.
Mentorship and Guidance: Provide guidance and support to less experienced CRAs or site staff as needed, sharing expertise and best practices.
Documentation and Reporting: Prepare and submit accurate and timely monitoring visit reports, follow-up letters, and other required clinical documentation.
Regulatory Submissions Support: Assist with regulatory document collection and review, ensuring all necessary documentation is in place for site activation and ongoing compliance.
Travel Readiness: Be prepared for regular travel within Belgium to conduct on-site monitoring activities.

Requirements

Clinical Research Experience: A minimum of 4-5 years of independent clinical monitoring experience, preferably within a CRO environment.
Therapeutic Area Knowledge: Demonstrated experience in gastroenterology or inflammatory bowel disease (IBD) clinical trials is highly advantageous.
Language Proficiency: Exceptional fluency, both written and verbal, in French and Dutch is mandatory. Proficiency in English is also required.
Educational Background: A Bachelor's degree in a life sciences or health-related field is essential.
ICH-GCP Expertise: Thorough understanding and practical application of ICH-GCP guidelines and relevant regulatory requirements.
Independent Work Ethic: Proven ability to work autonomously, manage multiple priorities, and meet deadlines in a remote setting.
Communication Skills: Outstanding interpersonal, communication, and negotiation skills, capable of building rapport with diverse site staff.
Problem-Solving Abilities: Strong analytical and problem-solving capabilities with a keen eye for detail.
Technical Proficiency: Competence with electronic data capture (EDC) systems, clinical trial management systems (CTMS), and standard office software.
Flexibility for Travel: Willingness and ability to travel extensively throughout Belgium for site visits as required.

What You'll Gain

Meaningful Impact: Contribute directly to groundbreaking research that profoundly improves the lives of patients suffering from gastrointestinal diseases.
Purpose-Driven Culture: Join a global company where scientific rigor, operational excellence, and a deep sense of purpose are at the core of everything we do.
Professional Growth: Unlock continuous learning and development opportunities within a supportive and innovative environment.
Work-Life Balance: Benefit from a fully remote work model, offering flexibility and autonomy in managing your daily schedule.
Collaborative Team: Become part of a passionate, international team of experts dedicated to making a difference.
Reinvested Success: Work for an organization that channels its profits back into scientific research, advanced technology, and its people, fostering a truly sustainable and forward-thinking environment.
Cutting-Edge Research: Engage with leading-edge science, supporting a significant portion of IBD compounds in development.