Clinical Research Associate II

Clinical Research Associate II

Duties: Assists in the development of clinical trial protocols; participates in the development of the overall clinical plan, drafts protocols, and coordinates the protocol review and approval process, to include submissions to regulatory agencies. Conducts clinical trial site initiation visits; advises and trains site personnel on sponsor and regulatory requirements for study conduct; participates and/or conducts site meetings and multi-center investigator meetings and prepares reports. Participates in the identification of potential investigators and clinical sites, both nationally and internationally; conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites. Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies. Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems, and clarifies and/or obtains changes to data as appropriate. Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up; assembles necessary documents, conducts site termination visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study termination reports. Performs miscellaneous job-related duties as assigned.
Qualifications: BS/BA degree and 2-3 years CRA monitoring experience. Requires specialized support experience, office management skills, basic accounting experience, knowledge of and experience with computer, printers, fax and other automated office equipment. Requires good computer skills, such as Word, Excel, PowerPoint and MS Office. Preferred Skills: Self directed and takes initiative, highly organized, able to coordinate multiple projects with maximum efficiency, strong sense of personal responsibility for quality of work including accuracy, reliability, completeness, timeliness and presentation. Requires the ability to evaluate a given situation, identification of issues and present observations and recommendations to others.