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Under supervision, coordinates daily activities and operations of clinical research studies. Responsible for screening and enrolling patients, monitoring protocol implementation, completing required forms and reporting results, and regulatory submissions. Conducts data collection activities and may prepare analytical reports on study results. Follows established clinical study standards and procedures to plan and conduct clinical research studies. Maintain open communication with team members to ensure proper study progress.
Job Responsibility
Consents and enrolls patients for research studies by providing detailed information on the Research Study to patients and families
Is responsible for understanding and adhering to all policies and procedures and responds to all inquiries
Obtains informed consent and enrolls patients in research studies
Reviews clinical information to identify patients meeting study inclusion criteria
Serves as liaison to the families/patients in the research studies, conducted at both on site and off-site locations, guiding and advising them throughout each phase of the study
Coordinates follow up visits as necessary
Acts as a resource to study participants, addressing any concerns they may have
Troubleshoots resolution of any issues that may arise throughout the study
Coordinates and prepares documentation needed for Institutional Review Board (IRB) on submissions, for PI approval
Tracks progress from submission to approval
Assist in developing supportive study documents such as informed consent forms, monitoring templates, study subject tracking tools, monitoring forms, study manuals, and training materials, as required for a study
Assist with the tracking and compilation of enrollment information
May assist with preparation of manuscripts and reports to be submitted to academic journals
May help train and orient newly hired study personnel
Coordinates activities with various departments to ensure correct testing/processing and sends clear instructions to each study
Monitors and reviews data collection and data entry, and informed consent procedures ensuring consistency of application for each study
Requirements
Bachelor's degree in a science field
0-1 years of professional experience
What we offer
flexible schedules
affordable health, vision and dental insurance
child care and student loan subsidies
generous levels of time off
403(b) Retirement Savings plan
Pension
Tuition and certain License and Certification Reimbursement