Clinical Research Associate II - Senior

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 to the most rigorous standards of quality and timely delivery. • 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. • Maintain clinical trial tracker. • Organize and present content at Investigator Meetings. • Participate in the development of Case Report Forms and clinical trial documents. • Act as contact for clinical trial supplies and other suppliers (vendors). • Prepare and review Standard Operations Procedures and Working Instructions as well as template documents.

Requirements

• Bachelor’s degree preferably in life science or nursing, or you have a 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)