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Clinical Research Associate (CRA) (Management)

Ascendo Resources

This is a Contract position in Middletown, DE posted October 13, 2021.

CLINICAL RESEARCH ASSOCIATE Catalyst Pharmaceuticals, Inc.

is seeking a Clinical Research Associate in Coral Gables, FL to work to help evaluate and recommend potential clinical sites, perform onboarding 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.

Position requires 25/35% travel to clinical sites throughout North America.

Bachelor’s in a science related field required, along with at least 36 months of experience in positions involving coordinating or assisting with pharmaceutical trials and knowledge of applicable clinical research regulatory requirements; including Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines and background and experience in reviewing, analyzing and understanding clinical trial data and the resulting statistics.

Contact Brian Elsbernd, Chief Legal and Compliance Officer, by phone at 305-420-3234 or e-mail at Job Requirements: Utilize clinical knowledge to improve clinical compliance on internal processes and at external clinical sites Maintain responsibility for clinical study activities at multiple clinical sites for several ongoing clinical studies Provided for clinical services delivery Execute clinical research studies with human subjects at MCHS Arising during clinical trial execution Governing the conduct of clinical trials NO RELOCATION ASSISTANCE Assist clinical teams in evaluating the progress of vendor contracts as the clinical program Provide leadership in clinical trial activities Generate clinical evidence for selected products Maintain ongoing clinical research site correspondence and site files Conduct clinical visits and attend patient treatment days as needed to support the clinical project Providing analyzes for robust clinical claim support Supporting clinical research or similar experience in a medical/scientific area Provide coverage to clinical contact telephone lines Provide clinical input to project risk assessments Observe, monitor and report clinical trends by keeping current with clinical results for assigned sites Managing the planning, implementation, and tracking of clinical monitoring processes, administration of clinical trials and maintaining an overview of the clinical trials Ensure clinical protocols and statistical methods meet sound and efficient statistical and clinical trial methodologies Provide support to the clinical affairs staff by monitoring data and ensuring clinical study documentation be Provide clinical administrative support to the study teams

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