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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:
Reviews clinical information to identify patients meeting study inclusion criteria
Consents and enrolls patients for research studies by providing detailed information on the Research Study to patients and families
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
Is responsible for understanding and adhering to all policies and procedures and responds to all inquiries
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
Conducts data collection activities and may prepare analytical reports on study results
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 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
May assist with preparation of manuscripts and reports to be submitted to academic journals
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.
Requirements:
Bachelors Degree
Analytical skills to gather and interpret data
Excellent organizational skills and attention to detail
Effective communication and writing skills to provide critical information to team members, patients, and families with ability to triage and escalate concerns to appropriate leadership
Problem-solving, troubleshooting abilities and resourcefulness.
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