Clinical Research Associate - II

September 15

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Discovery of HLA-restricted tumor-associated peptides as cancer targets • Biomarkers • Immunomonitoring • Peptidomics & mass spectrometry • Standardized PBMC collection

201 - 500

Description

• Responsible for the clinical monitoring activities for assigned clinical trial sites in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and SOPs. • Support clinical trial site feasibility. • Conduct all aspects of clinical monitoring for clinical trials including site visits for qualification, initiation, routine monitoring, and close-out. • Conduct all aspects of site management as prescribed in the clinical trial specific functional plans. • Review progress of clinical trials, especially patient recruitment and clinical trial data capture, and initiate appropriate actions to achieve objectives. • Support the maintenance of the Investigator Site Files and Trial Master Files. • Prepare accurate and timely monitoring visit reports.

Requirements

• Bachelor’s degree preferably in life science or nursing, or comparable education. • 5 - 7 years of on-site monitoring experience in the pharmaceutical/ biotechnology industry. • Understanding of medical oncology terminology and science. • Excellent communication and interpersonal skills, with the ability to build strong relationships with trial site staff and internal team members. • Strong organizational skills, with the ability to manage multiple projects and meet deadlines. • In-depth knowledge of ICH-GCP, FDA, EMA, and applicable local regulations and laws. • Valid Driver’s license. • Demonstrated computer skills, including Microsoft Office and clinical trial systems (i.e., eTMF, CTMS).