Principal Clinical Research Associate (In-House Principal CRA)

Responsibilities will include, but not be limited to: Develops site and study documentation such as training materials, protocols, plans, tracking reports, study manuals, and regulatory submissions for clinical research studies. In-house monitoring to study and procedure instructions of CRF’s and study regulatory files. Support Clinical staff for audit readiness and preparations. Review study processes and documentation for GDP, GCP, and regulatory compliance. Maintains documentation of all clinical research activities, e.g. site communications, correspondence, inventory information, etc. Duties include electronic and/or hardcopy file maintenance. Monitor and track site and subject enrollment, track milestones and manage trial invoices. Prepares study site and in-house materials and meeting arrangements for study and site initiations, investigator meetings and other study meetings. Prepares and provides materials for vendor/contractor training, including meeting arrangements, conduct and documentation. Supports Inventory Administration including all documentation for shipping, receiving and returned goods. Supports data management activities in CRF development, validation and verification rules and other reporting/analysis activities, reimbursement for sites and preparation of CEC and DMSB materials. Manages other In-House CRAs or provides mentorship, as assigned. Supports department activities as required.