clinical research associate.

For the Clinical Research Associate position the company offers the following: 

• competitive remuneration package.
• clear vision to establish a strong presence in a fast-growing, pharmaceutical environment.
• opportunity for further career evolution.

This Clinical Research Associate will be responsible for the following: 

• Conduct site initiation, routine monitoring (phone/video calls, onsite visits), and close-out visitsin accordance with study protocols, SOPs, and applicable regulations. The most of visits areconducted remotely.
• Ensure sites are adhering to protocol requirements, GCP, and regulatory guidelines.
• Act as the primary contact for study sites, addressing issues and facilitating resolution in a timelymanner.
• Assist in site identification, feasibility assessments, and initiation activities to ensure timely studystart-up.
• Build strong relationships with investigators, serving as a bridge in collaboration betweensponsors and sites. Site relationship management.
• Manages site contract communications and oversees site payment tracking, ensuring timelyexecution of site agreements, and coordinating with the contracts team as needed.
• Assist in the initial preparation and organization of the ISF, ensuring that all essential documents are included and filed correctly.
• Ensure that the ISF is audit-ready, with all necessary documents correctly filed, signed, and up to date.
• Provide training and guidance to site staff on maintaining the ISF in accordance with regulatory and study-specific requirements.
• Collect and perform quality check of documents from the site and ensure timely upload into the TMF.
• Manage documents findings according to internal QC performed by Lead CRA and Clinical Trial Assistant Perform data review, source data review (SDR) and source data verification (SDV), to ensure accuracy and completeness of data collected, as defined by monitoring/quality review plan.
• Identify and document any discrepancies, follow up with sites to resolve data queries, and ensure corrections are implemented.
• Provide training to site staff on study protocols, GCP, ISF management, and applicable regulations or study specific process.
• Collaborate closely with sites to address study-related issues and ensure protocol adherence, including timely resolution of queries and support for site recruitment.
• Maintain regular communication with the project team, provides updates on site performance
• and escalates/reports any sites issues.
• Prepare comprehensive visit reports and follow-up/confirmation letters (where applicable), ensuring timely submission and documentation.
• Regularly update site status, including enrolment progress and issue resolution, in the CTMS or other reporting tools.
• Prepare sites for audits and inspections with the support of QA team, ensures all documentation, including the ISF, is up to date and compliant.
• Support sites during audits and assist in addressing any findings or observations.

The perfect candidate for the Clinical Research Associate position will need to acquire the following: 

• Bachelor’s degree in life sciences, healthcare, or related field.
•  Strong understanding of GCP and regulatory requirements
•  Proficient in EDC and CTMS systems.
• Excellent organizational and communication skills.
• Attention to detail and ability to work independently.
• Ability to work collaboratively within a dynamic international team.

• 2-3 years of experience in clinical research.

Does this role sounds like you or someone you know? We want to hear from you today. Apply online now!

Have some questions first? Call our office at +30 2166001308 and ask for Calypso Aronis. Otherwise, feel free to contact me at caronis@randstad.gr. 

Please note that for transparency and equity reasons, only those applications made online via our site will be assessed. After the screening of all the CVs received, we will only contact the candidates who meet the requirements of the job to arrange an interview. ​ All applications are considered strictly confidential.