Clinical Research Coordinator C (Department of Neurology)

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Posted Job Title

Clinical Research Coordinator C (Department of Neurology)

Job Profile Title

Clinical Research Coordinator C

Job Description Summary

This position will be a resource for best practices of managing major clinical trials. The coordinator will be responsible for managing both study drug trials and device trials, as applicable. They will collaborate with internal study teams, nursing units, and sponsors, working to efficiently run all phases of clinical trials. They will be a resource to other members of the team, helping to train newer staff members, identify and problem solve challenges in study management and site standard operating procedures (SOPs), and will oversee and assist with the implementation of new trials.

Job Description

This position will function as lead coordinator on several complex phase I-IV studies. They will be responsible for maintaining protocol compliance, enrollment and retention of subjects, management of subject visits, management of study drug or devices, and regulatory submissions. This includes recruitment, consent, and screening of patients into the protocol, scheduling subject visits, monitoring and ensuring adherence to protocol requirements, and subject training. They will maintain organized study documentation including source documents, case report forms, subject binders, regulatory binders, and electronic data entry. They will be responsible for collecting, reviewing, and reporting study data, completing data entry, and resolving queries. They will manage all aspects of subject visits including subject training and retention, completion of assessments and questionnaires (PROs), and collection, processing, and shipping of laboratory samples. Assessments may include ECG/EKGs, vital sign collection, cognitive testing, training subjects on study devices or programs, review of medications and medical history, review and reporting of adverse events, etc.

This position will participate in study start up, ongoing study maintenance, monit