Senior Clinical Research Associate - Contractor

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Corbus Pharmaceuticals

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cancer • immunotherapy • immuno-oncology • nectin-4 biology • integrin biology

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Description

• Responsible for all aspects of study site monitoring, including routine monitoring and closeout of clinical sites. • Conduct qualification, initiation, monitoring, and closeout visits at research sites. • Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff. • Completion of monitoring reports and follow-up letters, including summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. • Monitor site performance and subject recruitment/retention success, offering suggestions for improvement and implementing action plans in conjunction with the Sponsor.

Requirements

• Minimum of 4-5 years of clinical monitoring or relevant clinical trial experience managing clinical sites. • Experience of working in early phase clinical studies and with a small Biotech. • Must maintain a valid driver’s license and the ability to attend monitoring sites. • Strong communication and presentation skills. • Must be detail-oriented and efficient in time management. • Working knowledge and experience with clinical systems (i.e. Electronic Data Capture (EDC) systems, TMF and CTMS). • Thorough knowledge of ICH-GCP guidelines, human subject protection (HSP) and patient privacy requirements, clinical trial monitoring, Serious Adverse Event (SAE) reporting, and/or regulatory compliance.