Senior Clinical Research Associate I

This is a fully remote position, open to applicants in Greece.

📋 Description

• Oversee and supervise assigned investigator sites from the initiation phase through to database lock.

• Ensure adherence to Study Monitoring Plans, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, and applicable regulations.

• Collaborate with Site Care Partners prior to site activation on essential feasibility and site selection tasks, Pre-Trial Assessments (PTAs), site activation checklists, finalization of the Informed Consent Document (ICD), and Site Initiation Visits (SIVs).

• Actively guide and train Clinical Research Associates (CRAs) as needed, facilitating their professional growth and operational skills.

• Function as a Subject Matter Expert (SME) for CRA-related activities and engage in regional or local task forces and process enhancement efforts.

• Identify, address, and manage intricate issues related to investigator sites.

• Develop and execute effective Corrective and Preventive Actions (CAPAs), oversee Quality Event remediations, assist with sponsor regulatory interactions/inspections, and lead the development of Audit Observation CAPAs.

• Collaborate with SCPs, Country SOMs, Clinicians, Recruitment Specialists, and Clinical Data Scientists. Provide support for enrollment, tackle complex protocol questions, and perform remote assessments of e-diary data.

• Supervise site-level Adverse Events (AEs) and Serious Adverse Events (SAEs), work with the Drug Safety Unit, manage investigational product oversight (including accounting, storage, and destruction), assist in database release, and partake in co-monitoring activities as necessary.

⛳️ Requirements

• A Bachelor’s degree in Life Sciences, or a professional qualification in nursing, pharmacy, medical fields, or an equivalent area.

• Comprehensive understanding of clinical trial methodologies, ICH/GCP standards, FDA regulations, and local country laws.

• At least 3 years of pertinent experience in clinical research site monitoring (with a preference for 2 years in Oncology).

• Prior experience in global clinical trials is essential.

• Proficiency in English and the local language(s) of the country of employment.

• Therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Professional development opportunities