Clinical Research Associate, Randstad

Randstad

Location:
Greece, Athens

Category:
Research and Development

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

We are currently looking for a Clinical Research Associate on behalf of our client, a well established company in the field of pharmaceutical products.

Job Responsibility:

Conduct site initiation, routine monitoring (phone/video calls, onsite visits), and close-out visits in accordance with study protocols, SOPs, and applicable regulations
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 timely manner
Assist in site identification, feasibility assessments, and initiation activities to ensure timely study start-up
Build strong relationships with investigators, serving as a bridge in collaboration between sponsors and sites
Manages site contract communications and oversees site payment tracking, ensuring timely execution 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

Requirements:

2-3 years of experience in clinical research
Ability to work collaboratively within a dynamic international team
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

Additional Information:

Job Posted:
May 11, 2025

Expiration:
May 30, 2025

Employment Type:

Fulltime

Work Type:

Remote work

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Clinical Research Associate

Randstad

Location:Greece, Athens

Category:Research and Development

Contract Type:Not provided