Senior Clinical Research Coordinator - Psychiatry

Position Summary

The Cruchaga lab at the NeuroGenomics and Informatics Center is hiring a Senior Clinical Research Coordinator. This person will oversee and coordinate complex or multi-site clinical research studies, serve as a resource to provide comprehensive information to clinical research staff, promote smooth clinical operations, prepare regulatory compliance documents, coordinate interaction with other departments, and supervise clinical research coordinators and staff.

Primary Duties & 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.
• Performs other duties incidental to the work described above.

Required Qualifications

• Bachelor's degree or combination of education and/or experience may substitute for minimum education.
• Clinical Research (3 Years) experience.
• Basic Life Support certification must be obtained within one month of hire date. (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirement.)

Preferred Qualifications

• Master's degree.
• Clinical Research Management, Clinical Study Protocols, Computer Systems, Database Management, Data Entry, Detail-Oriented, Freezerworks (Software), Interpersonal Communication, Microsoft Office, Ordering Supplies, Organizing, Participant Recruiting, Research Projects, Research Support, Written Communication.

Salary

$64,300.00 - $99,700.00 / Annually