Senior Clinical Research Associate

November 8

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Catalyst Pharmaceuticals, Inc.

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Neurology • Neuromuscular • Pharmaceuticals • Rare Disease

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Description

• Sr. Clinical Research Associate (CRA) will play a vital role in the successful management of Catalyst Clinical Trials from study startup through study completion. • The responsibilities include ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH/GCP guidelines, and all applicable regulatory requirements. • This is a remote, home-based role. • Participate in site/vendor selection process. • Plan and perform various study start-up activities. • Perform site evaluation, initiation, monitoring, and close-out visits remotely and on-site, per study requirements. • Be responsible for planning, overseeing, and conducting correspondence with the assigned sites. • Oversee clinical research sites to ensure adherence to SOPs, ICG/GCP and regulatory requirements. • Track day to day site activities and have current data available for clinical operations management team upon request. • Assist in the development of content and/or provide technical expertise for development of essential clinical documents. • Foster strong relationships with sites and vendors. • Be able to work with and oversee CROs for fully outsourced studies. • Support audit/inspection preparation to ensure Catalyst as well as sites’ inspection readiness.

Requirements

• Bachelor’s degree with at least 5 years of relevant clinical trials experience. • Extensive knowledge of applicable clinical research regulatory requirements, including ICH/GCP guidelines • Experience in CTMS, EDC and eTMF systems. • Experience in reviewing, analyzing, and understanding clinical trial data. • Ability to prioritize within a busy environment and produce work to meet tight deadlines. • RN and /or MS preferred. • Ability to travel up to 50% of time as needed to meet the assigned study requirements.