Sr Clinical Research Associate (Serbia)

Are you passionate about making a real difference in the lives of patients? Do you thrive in an environment where your work directly contributes to groundbreaking medical advancements? Alimentiv invites you to join our dedicated team as a Senior Clinical Research Associate. Here, you won't just monitor trials; you'll play a pivotal role in advancing therapies for gastrointestinal diseases, our singular focus and the very heart of our mission. If you're ready to channel your expertise into meaningful research and build something truly impactful, we genuinely want to connect with you.

Overview

Alimentiv stands as a global Contract Research Organization (CRO) with over three decades of unwavering commitment to gastrointestinal health. We are a private, profit-with-purpose company, diligently reinvesting our success back into scientific research, technology, and our exceptional people. This Senior Clinical Research Associate position is a key opportunity for an experienced professional to independently manage critical clinical site monitoring and site management activities. This role offers the flexibility of a fully remote setup, part of Alimentiv's global commitment to talent, though your primary site management activities will focus on investigative sites across Serbia and Croatia, spanning from study start-up through close-out. You will serve as the principal contact for these sites, ensuring meticulous compliance with protocol requirements, Good Clinical Practice (GCP), and all relevant regulatory standards.

Key Responsibilities

Independently manage and conduct all aspects of on-site and remote monitoring visits for assigned clinical trials in Serbia and Croatia.
Serve as the primary point of contact for investigative sites, fostering strong relationships and facilitating effective communication.
Ensure strict adherence to study protocols, standard operating procedures (SOPs), GCP, ICH guidelines, and local regulatory requirements.
Conduct comprehensive source data verification, ensuring accuracy, completeness, and integrity of clinical trial data.
Oversee the resolution of data queries and discrepancies in a timely and efficient manner.
Provide comprehensive training and ongoing support to site staff regarding study protocols, trial procedures, and regulatory compliance.
Manage essential document collection, review, and maintenance throughout the trial lifecycle.
Participate in site selection, initiation, and close-out activities as required.
Identify and escalate potential issues or risks to project management, proposing proactive solutions.
Travel as needed to perform site visits within Serbia and Croatia.

Requirements

A minimum of three to five years of independent clinical monitoring experience, preferably within a CRO or pharmaceutical setting.
Demonstrated expertise in all phases of clinical trial monitoring, from site initiation to close-out.
In-depth knowledge of ICH-GCP guidelines, local regulatory requirements, and relevant ethical considerations.
Strong understanding of clinical trial processes, medical terminology, and data management principles.
Exceptional organizational skills and meticulous attention to detail.
Excellent written and verbal communication skills in English, Serbian, and Croatian.
Ability to work autonomously, manage multiple priorities, and meet tight deadlines.
Proficiency with clinical trial management systems (CTMS), electronic data capture (EDC), and other relevant software.
A bachelor's degree in a life science or related field is highly preferred.
Ability to travel frequently within Serbia and Croatia.

What You'll Gain

The profound satisfaction of contributing to life-changing research that directly impacts patients suffering from gastrointestinal diseases.
An opportunity to work with a leading global CRO renowned for its deep therapeutic expertise and scientific rigor.
A collaborative, purpose-driven environment where your professional growth is valued and supported.
The chance to make a tangible difference in the advancement of therapies, including our significant involvement with IBD compounds.
Access to continuous learning and development opportunities within a growing, innovative organization.
Be part of a company that truly invests in its people, technology, and scientific discovery.