Senior CRA / Site Monitor II

Excelya Group; Kentucky; Hybrid; USD 70,000 - 100,000; Full time

Job summary

Excelya Group seeks a Senior CRA/Site Monitor II to oversee clinical trial monitoring for oncology studies, ensuring data integrity and regulatory compliance. Travel to sites will be required, with some remote monitoring where allowed by local regulations.

The ideal candidate has 3 years of oncology monitoring experience, strong communication skills, and fluency in English and Greek. Join a dynamic clinical operations team and contribute to high-quality trials.

Qualifications

• 3 years of clinical monitoring experience in oncology.
• Fluency in English and Greek.
• Strong communication with stakeholders and teams.
• Adaptability to new technologies and processes.
• Willingness to travel for site monitoring.
• Knowledge of ICH-GCP and regulatory guidelines is a plus.

Responsibilities

• Ensure regulatory, ICH-GCP, and protocol compliance and monitor site performance.
• Perform source data verification and ensure data accuracy.
• Coordinate with Site Manager and investigators to ensure inspections readiness.

Skills

Fluency in English

Fluency in Greek

Effective communication with stake-hol

Adaptability to new tech/processes

Problem-solving during process changes

Willingness to travel

Education

Bachelor’s or Science degree in related field

Job description

Join Excelya, whereAudacity, Care, and Energydefine who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Senior CRA/Site Monitor IIis responsible for making sure clinical trial data is accurate, high-quality, and follows all rules and guidelines (ICH GCP and local laws). Monitoring is done via on-site visits, with some remotely as needed. The role works closely with the Site Manager and other team members to ensure the site follows the study plan and is ready for inspections. It also involves regular contact with local investigators and institutions.

Main Responsibilities:

• Ensures regulatory, ICH-GCP, and protocol compliance. Evaluates site and staff performance, recommends site-specific actions, escalates key issues promptly, and develops action plans. Maintains current knowledge of ICH-GCP, regulations, and company SOPs/processes.
• Checks the site and external facilities, equipment supplies (clinical non-clinical) continue adequate conduct trial with their expiry dates (as applicable).
• Conducts source document review and verification or appropriate site source documents and medical records.

Beyond that, you will also be able to:

• Manage reporting of protocol deviations and appropriate follow up.
• Enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Conduct follow up for escalated adverse event monitoring (AEM) report query.

Moreover:

• Per the Clinical Monitoring Plan (CMP) or SMP : Ability to conduct monitoring activities using different methods (e.g., both on site and remote) where allowed by country regulations.
• For assigned activities : understand project scope, budgets, and timelines, manage site level activities and communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals and targets.

At Excelya,taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.

•Experience: 3 years of clinical monitoring experience in oncology is required.

•Skills: Effective communication with stakeholders, Adaptability to new technologies and processes, Problem-solving during process/system changes, Willingness to travel.

•Education: Bachelor’s degree or Science degree in a related field, or equivalent education/experience.

•Languages: Fluency in Greek and English language.

Why Choose Excelya?

At Excelya, we lead with Audacity, act with Care, and move with Energy. We nurture your potential through high-impact projects, give your talents the space to shine, and push boundaries to elevate every patient’s journey. Here, you're not just doing a job—you’re becoming a key part of something bigger.

So, if you're ready to excel with purpose, let’s write the next chapter together.

Apply today, become an Excelyate!