The Clinical Trials Project Specialist is a full-time/in-house position. The Clinical Trials Project Specialist:
* Is responsible for coordinating and managing contracted homecare services in the support of sponsored projects and Phase I - IV clinical studies in a variety of therapeutic areas. * Is responsible for on-time, on-budget provision of deliverables for assigned projects. * Defines and manages project resource needs and establish contingency plans for key resources. * Participates in the development and revision of documents and study support materials (homecare training manuals, homecare visit forms, etc). * Tracks progress of projects and identify appropriate actions to achieve target objectives. * Serves as the lead point of contact for Sponsors, Investigator Sites and Homecare Agencies participating in the study. * Reviews documentation/case report forms for completeness and accuracy. * Reviews, verifies, and approves invoices for study-related services. * Maintains study files and trial tracking systems. * Liaises with vendors, pharmacies, and homecare agencies. * Initiates improvements to enhance the efficiency and the quality of the work performed on assigned projects. * Interacts with internal work groups to evaluate needs, resources and timelines. * Conducts literature searches; assist in the development of data collection instruments; and participate in regular meetings with clients/sponsors. * Assists with training, mentoring, and development of new Clinical Research Project Managers, as the need arises. * Performs other related duties as directed by supervisor.
Comprehensive knowledge of ICH / GCPs. Proficient computer skills.
Education: Bachelors degree preferably in a scientific or nursing discipline.
Due to the precise requirements of this position, we will only be contacting candidates that meet all of the listed criteria. If you are qualified and interested in this excellent career opportunity, please reply to this ad immediately with your CV and availability.