Description
Main ResponsibilitiesWorks under general supervision, and participates in the design, planning, implementation and overall direction of clinical research projects; May co-ordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well.
Receives general instructions; plans and prepares studies. Travels to field sites to monitor studies. Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents. Works with Data Management and Biostatistical staff on the design of documents and processes for the collection of study data from participating sites. Assumes accountability for the collection and maintenance of regulatory documentation. Assists with the coordination of training and certification of study site personnel. With guidance, ensures accurate and complete study management/data collection and transfer into the data management system. Ensures site compliance with regulations and study protocol. Conducts reference material testing in-house. Supports the organization of investigator meetings, as necessary. Establishes, as appropriate, internal/cross-functional/customer relationships. Uses discretion and independent judgement to recommend solutions to basic problems that the individual or team projects. Assists, prepares and manages study timelines. Participates in Project Team Meetings. Keeps informed of trends and developments in clinical research.
Education Requirement: B.S. or M.S. in Biology, Chemistry, Molecular Biology or related discipline.
Travel: Able to accommodate 15-35% travel during peak periods
To find out more about Real please visit www.realstaffing.com