The Cruchaga lab at the NeuroGenomics and Informatics Center is looking to hire a Senior Clinical Research Coordinator to oversee and coordinate complex or multi-site clinical research studies, ensuring smooth operations and regulatory compliance.
Requirements
- 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).
- Clinical Research Management
- Clinical Study Protocols
- Computer Systems
- Database Management
- Data Entry
Responsibilities
- Acts as the primary liaison to PI in developing plans for clinical research projects; 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.
- 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.
- Manages protocol study start up and study launch, submission, and maintenance of essential regulatory documents. 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.
- 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. Assists in budget review and invoice tracking.
- Provides guidance and supervision to members of research team in the implementation and evaluation of clinical research; trains new staff; serve as lead or as point of reference for other research coordinators for questions, staff scheduling, feedback on performance. Participate in the hiring, training, and evaluation of clinical research staff.
- Assists in scheduling and facilitating site visits by external and internal monitors and auditors.
- Provides study coordinator functions and performs all duties associated with the coordination and implementation of clinical research study/projects, data collection, and the management of data generated by study protocols; consents participants for non-therapeutic clinical trials and performs blood draws and other specimen collection as needed.
Other
- Bachelor’s degree or combination of education and/or experience may substitute for minimum education.
- Supervision
- Master's degree
- Communication
- Detail-Oriented
