Senior Clinical Research Associate — Remote (Italy)

TFS HealthScience; Roma; Remote; EUR 53,000 - 55,000; Full time

Benefits offered by this job

Lunch vouchers

Health insurance

Pension plan

Car allowance where applicable

Job summary

TFS HealthScience is seeking a Senior Clinical Research Associate to work remotely from Italy. You will monitor sites (on-site and remote), ensure data integrity and patient safety, and support regulatory compliance across studies in collaboration with project teams.

The role requires 5+ years of trial monitoring experience, oncology exposure preferred, and strong English skills. Expect substantial travel, with a permanent contract and competitive compensation.

Qualifications

• Bachelor's Degree, preferably in life science or nursing; or equivalent.
• At least 5 years of experience monitoring clinical trials (3 years oncology – early phase desirable).
• Able to work in a fast-paced environment with changing priorities.
• Understand basic medical terminology and science related to the drugs and therapeutic areas.
• Possess knowledge of GCP regulations and ICH guidelines.
• Ability to work independently as well as in a matrix team.
• Fluent in English and excellent organizational skills.
• Willingness to travel up to 60–80%, overnight and abroad if applicable.

Responsibilities

• Monitor on-site and remote trials according to GCP/ICH and SOPs.
• Perform monitoring activities to ensure subject safety and data integrity.
• Verify informed consent and protocol compliance at sites.
• Review CRFs and source documentation for accuracy.
• Manage Investigational Product accountability and logistics as needed.
• Document monitoring visits and actions taken in reports and tracking systems.
• Provide sites with issue lists and required corrective actions.
• Ensure ISF, eTMF, and CTMS are maintained per regulations and local rules.
• Assist in audits and inspections and participate in follow-up activities.
• Order, ship, and reconcile clinical supplies for sites when applicable.

Skills

Clinical trial monitoring

GCP/ICH knowledge

English fluency

Communication skills

Travel readiness

Education

Bachelor's Degree in life sciences

Nursing degree or equivalent

Tools

CTMS

eTMF

Job description

TFS HealthScience is seeking a Senior Clinical Research Associate to work remotely from Italy. You will monitor sites (on-site and remote), ensure data integrity and patient safety, and support regulatory compliance across studies in collaboration with project teams.

The role requires 5+ years of trial monitoring experience, oncology exposure preferred, and strong English skills. Expect substantial travel, with a permanent contract and competitive compensation.