Imagine a role where your daily work directly contributes to breakthroughs for patients suffering from serious gastrointestinal diseases. At Alimentiv, that's not just a dream, it's our driving purpose. For over three decades, our passionate team has been at the forefront of GI research, fueling scientific discovery and operational excellence that has supported a huge majority of IBD treatments currently in development. We are a unique company, choosing to invest our success back into vital research, cutting-edge technology, and, most importantly, our incredible people. If you are ready to apply your expertise to truly meaningful work, to build something impactful, and to see your efforts translate into real change for patients, then we absolutely want to connect with you.

Overview

As a Senior Clinical Research Associate at Alimentiv, you will join our dedicated team and play a pivotal role in ensuring the successful execution of critical clinical trials. This is a fully remote position, though your focus will be on independently managing all aspects of clinical site monitoring and comprehensive site management activities across Portugal and Spain. From initial study start-up through to final close-out, you will serve as the primary point of contact for investigative sites in these countries. Your mission will be to guarantee unwavering compliance with study protocols, Good Clinical Practice (GCP) guidelines, and all relevant regulatory requirements, ultimately driving the integrity and quality of our research.

Key Responsibilities

Independent Site Monitoring: Conduct comprehensive monitoring visits, both remote and on-site within Portugal and Spain, to assess protocol adherence, data accuracy, and regulatory compliance.
Site Management Leadership: Act as the lead point of contact for assigned investigational sites, providing expert guidance and proactive support throughout the entire lifecycle of a study.
Regulatory Compliance: Ensure all site activities strictly follow ICH-GCP guidelines, applicable regulatory requirements, and Alimentiv's Standard Operating Procedures (SOPs).
Data Quality Assurance: Perform thorough source document verification, resolve data queries efficiently, and ensure the accuracy and completeness of case report forms.
Effective Communication: Foster strong, collaborative relationships with site staff, investigators, and internal project teams, facilitating clear and timely communication.
Issue Resolution: Identify, document, and promptly resolve any site-related issues or deviations, escalating when necessary.
Documentation Expertise: Prepare and submit accurate monitoring reports, follow-up letters, and other essential study documentation within specified timelines.
Mentorship & Training: Potentially provide guidance and support to less experienced CRAs, contributing to team development.
Travel: Expect regular travel to clinical sites within Portugal and Spain as required for monitoring activities.

Requirements

A Bachelor's degree in a life science, nursing, or a related healthcare field is essential.
Extensive experience, typically 4+ years, as a Clinical Research Associate with significant independent monitoring responsibilities.
Proven experience monitoring clinical trials across various phases.
Demonstrated expertise in ICH-GCP guidelines, national and local regulatory requirements for clinical trials.
Fluency in English and Portuguese, both written and verbal, is a mandatory requirement. Knowledge of Spanish would be a significant advantage.
Exceptional communication, interpersonal, and negotiation skills.
Ability to work autonomously, manage multiple priorities, and meet deadlines in a fast-paced environment.
Strong problem-solving abilities and keen attention to detail.
Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
Willingness and ability to travel frequently within Portugal and Spain.

What You'll Gain

Purpose-Driven Impact: Contribute directly to advancing therapies for patients with gastrointestinal diseases, making a tangible difference in lives.
Collaborative Environment: Join a global team of dedicated professionals united by a shared mission, fostering learning and growth.
Professional Development: Expand your expertise within a specialized CRO, with opportunities for leadership and career advancement.
Innovative Culture: Be part of a company that reinvests its success into scientific research and cutting-edge technology.
Flexibility: Enjoy the benefits of a fully remote position while making a direct impact on clinical sites in Portugal and Spain.
Competitive Compensation: Receive a competitive salary package reflecting your experience and contributions.