Oversees and coordinates complex or multi-site clinical research studies; serves as a resource to provide comprehensive information to clinical research staff by promoting a smooth operation, preparation of regulatory compliance and interaction with other departments; may supervise clinical research staff.
Requirements
- Clinical Research (3 Years)
- Clinical Research Management
- Clinical Study Protocols
- Database Management
- Research Projects
- Spreadsheet Analysis
- Statistical Analysis Software (SAS)
Responsibilities
- Acts as the primary liaison to PI in developing plans for research projects and discussing the interpretation of results; collaborates in the preparation of manuscripts for publication and preparation of grant proposals to sponsoring agencies; assists in the preparation of amendments to protocols and/or modifications to study design as appropriate.
- Serves as responsible for the development of forms, questionnaires and the application of research techniques; assists in writing instructional procedure manuals for study progress, data collection and coding; reviews journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.
- Designs, implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; identifies problems and/or inconsistencies and monitors participant’s progress to include documentation and reporting of adverse events; resolves IRB/protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency.
- Provides guidance to members of research team in the implementation and evaluation of clinical research; trains new staff; may serve as lead or as point of reference for other research coordinators for questions, staff scheduling, feedback on performance.
- Evaluates and interprets collected clinical data in conjunction with PI as appropriate; prepares oral or written presentations or reports and analyses setting forth progress trends and provides recommendations or conclusions of the same.
Other
- Supervision
- Basic Life Support certification must be obtained within one month of hire date.
- Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirement).
