Clinical Research Associate

Responsibilities: * Supervises and coordinates day-to-day activities of clinical sites and serve as the primary Sponsor contact with CROs and vendors related to assigned clinical projects. * Maintains all relevant site communications and both trial and site master files. * Participates in investigator site selection. * Conducts and coordinates activities associated with qualification, initiation, interim monitoring, study close out and audit visits as required. * Assists in development and review of protocol related documents, case report forms and monitoring plans. * Assists with the collaborative creation of study protocols, study reports, regulatory reports for discovery, verification, and validation studies, and support for ethical and regulatory submissions as required. * Communicates with internal departments as needed, including attending required meetings and following-up on action items. * Assists in development of departmental SOPs and personnel training programs. * Reviews study data and resolution of queries. * Travels to study sites based on project needs. Skills / Education: * BA/BS in a life science or other medical discipline. * 3-5 years of experience (or 5-8+ years for a Sr. CRA) at a Sponsor or CRO. * Sr. CRA requires experience as a Study Lead and/or Study Manager. * Medical device or in vitro diagnostic (IVD) experience strongly preferred. * Strong working knowledge of medical/scientific terminology and knowledge of FDA regulations, GCP, and ICH guidelines is required. * Excellent planning, problem solving skills, and communication skills with the ability to communicate effectively with all levels of the organization. * Ability to travel up to 30% * Proficiency with Office Suite and standard computer programs required.

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