Clinical Research Associate

Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.
We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.

If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you!

Job Overview

The Senior Clinical Research Associate (Sr. CRA) independently performs, coordinates and oversees clinical site monitoring activities, ensuring compliance with study protocols, Alimentiv and sponsor procedures, ICH-GCP guidelines and local regulatory requirements.

Serving as a primary liaison between investigative sites, Alimentiv and sponsors, the Sr. CRA plays a key role in the successful execution of clinical studies from site selection and start-up through monitoring and close-out. This role also provides guidance and mentorship to CRA I and CRA II colleagues and may participate in CRA assessment visits, co-monitoring activities, audits and inspections.

Key Responsibilities

• Independently conduct and document onsite and remote site management activities, including site qualification, initiation, monitoring and close-out visits, in accordance with applicable SOPs and study requirements.

• Serve as a primary point of contact for investigative sites, building effective working relationships and ensuring site questions, issues, action items and protocol deviations are followed through to resolution.

• Review source documentation and study systems to ensure clinical data is accurate, complete and compliant with protocol, regulatory and study requirements; manage and facilitate the resolution of data queries.

• Oversee site activation and ongoing site management activities, working with sites and cross-functional teams to achieve project timelines, milestones and recruitment objectives.

• Ensure site personnel are appropriately trained on study protocols, plans, systems, ICH-GCP requirements and project-specific expectations.

• Routinely review Investigator Site Files (ISF), Trial Master Files (TMF) and study systems for accuracy, completeness, timeliness and compliance, requesting outstanding documentation as required.