Senior Clinical Research Associate

<p>We are looking for a proactive and motivated Clinical Research Associate (CRA) to oversee clinical study monitoring and ensure that trials are conducted in full compliance with regulatory standards and guidelines.</p><p></p><p>Role:</p><p>Identify and select suitable clinical trial sites based on study requirements.</p><p>· Conduct site initiation visits to ensure the research team is well-informed on the study protocol and regulatory requirements.</p><p>· Perform regular monitoring visits to clinical trial sites to confirm adherence to the study protocol, Good Clinical Practice (GCP), and regulatory guidelines.</p><p>· Carry out close-out visits once the trial concludes to verify the accuracy of data, completion of necessary documents, and submission of required reports.</p><p>· Draft visit reports and contribute to the study progress reports for the project team and sponsor.</p><p>· Train the principal investigator and site staff on the study protocol, documentation, and study procedures.</p><p>· Ensure that investigators comply with GCP standards.</p><p>· Serve as the main point of contact between the sponsor and the investigator, facilitating communication and collaboration.</p><p>· Ensure proper organization and maintenance of documents in the Investigator Site File.</p><p>· Retrieve essential documents required for the Trial Master File.</p><p>· Address site concerns promptly to prevent delays in the trial.</p><p>· Monitor patient enrollment and site performance to ensure timely inclusions.</p><p>· Oversee patient safety, ensuring adverse events (AEs) and serious adverse events (SAEs) are properly reported.</p><p>· Manage the distribution and return of materials and products at sites.</p><p>· Perform source data verification to ensure the accuracy and completeness of site data.</p><p>· Track study progress to ensure recruitment, data collection, and monitoring milestones align with study timelines.</p><p>· Assist in regulatory document reviews related to EU legal representation activities</p><p><strong>Requirements</strong></p><p>· Bachelor’s degree in Life Sciences, Health, Pharmacy, or related field.</p><p>· Proficiency in GCP/ISO 14155 (valid certification required) and current regulations.</p><p>· At least 2 years of operational field experience as a CRA or a combination of CRA and other clinical research roles.</p><p>· Strong time management skills to handle multiple sites and responsibilities, with excellent multitasking abilities.</p><p>· Excellent verbal and written communication skills to liaise effectively between study sites and sponsors.</p><p>· Strong attention to detail and a problem-solving mindset.</p>