A Clinical Research Associate (CRA), also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials. At Catalyst, CRAs work to help evaluate and recommend potential clinical sites, perform on-boarding and training of new clinical sites, and monitor and audit activities, documentation, and data from clinical sites to ensure that the conduct, patient protection, and resulting data from Catalyst clinical sites is at the highest levels. In addition to addressing LEMS patients, we are currently investigating the safety and effectiveness of amifampridine phosphate for the treatment of patients with congenital myasthenic syndromes (CMS) and MuSK-positive myasthenia gravis (MuSK-MG), two additional rare diseases.

 Responsibilities: 

·       Support clinical studies and the process to identify/solve operational issues through internal and external partners

·       Responsible for monitoring visits planning and execution

·       Responsible for accuracy of monitoring reports and follow-up letter

·       Assurance that investigational sites adhere to regulatory compliance standards of SOPs, FDA, EMA and ICH guidelines

·       Assist in the development of content and/or provide technical expertise for development of essential clinical documents

·       Foster strong relationships with sites and vendors

·       Support audit preparation to ensure sites are ready and will meet requirements

·       Review data and statistical outputs to assess quality and integrity

 

Qualifications and Skill Requirements:

·       Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view

·       Ability to solve problems by being flexible and open to multiple solutions without being rigid

·       Independently motivated, detail oriented and good problem-solving ability

·       Excellent communication, writing and presentation skills

 Skills and Experience:

·       Requires a Bachelor’s degree with at least 3 years relevant clinical trials experience

·       Knowledge of applicable clinical research regulatory requirements; including GCP and ICH guidelines

·       Background and experience in reviewing, analyzing and understanding clinical trial data and the resulting statistics

·       Strong multitasking skills with significant attention to detail

·       Ability to prioritize within a busy environment and produce work to meet tight deadlines

·       RN and /or MS preferred 

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