University of South Florida Libraries ยท 5 hours ago
Sr Clinical Research Associate
Tampa, FL
Full-time
Onsite
Mid, Senior Level
$72K/yr - $90K/yr
3+ years expThe University of South Florida Libraries is seeking a Senior Clinical Research Associate to plan, organize, and manage resources for clinical research projects. This role involves overseeing project operations, training staff, ensuring compliance with regulations, and maintaining project documentation.
Higher Education
Responsibilities
Oversees and designs protocols and electronic case report forms
Develops manual of operations
Reviews medical protocol and prepares draft of document
Coordinates with protocol project manager and study chair preparation of final document for research staff training
Updates the protocols as needed and maintain document version control
Throughout the tenure of the medical protocol, update as needed with Study Chair as appropriate
Trains indirect and/or direct reports on policies and procedures, operations, adverse event resolution, protocol creation and review, case report form creation and review, and site data adherence and compliance
Monitors compliance of study procedures with Federal, state and university regulations
Ensures that documents such as eligibility forms and informed consent are appropriately gathered and maintained, HIPAA regulations are followed, and that infection control, and safety procedures are implemented
Manages addition of new sites to the network and develops and maintain policies, templates, and related documents for new site additions
Develops and interprets policy governing data systems, data collection procedures and database validation studies to be in compliance with federal guidelines (Good Clinical Practice, GCP)
Collects and analyzes data from clinical trials or other medical screening
Creates data bases based client information or medical records, and analyzes data
Coordinates conference calls and meetings and prepare necessary meeting documents (agendas, minutes, handouts, reports, etc.), develops related standards, templates and processes
Acts as point of contact and support for consortia research staff
Qualification
Required
Bachelor's degree in a field directly related to the program responsibilities and three years of professional experience
Master's degree in an area of specialization appropriate for the program and one year of professional experience
Compliance with Federal, state and university regulations
Management of project activities including training and supervising project staff
Development of protocols and operations manuals
Monitoring compliance of study procedures
Ensuring proper gathering and maintenance of documents such as eligibility forms and informed consent
Management of new site additions and development of related documents
Development and interpretation of policy governing data systems and data collection procedures
Collection and analysis of data from clinical trials or other medical screening
Coordination of conference calls and meetings
Preferred
Bilingual- Spanish
Certified in Clinical Research with a reputable clinical research society
Master's degree in Biological Science, Public Health, Health Science, Nursing or other directly related field
RN, State of FL
Phlebotomy trained
Experience in REDCAP, EPIC, eBinder software (FLORENCE) or data management/Clinical Research tracking software
Prior management experience preferred
Ability to work independently and in a group setting
Creative problem solver
Ability to manage tight deadlines
Impeccable time management
Excellent verbal and written communication
Benefits
Medical, dental and life insurance plans
Retirement plan options
Employee and dependent tuition programs
Generous leave
Hundreds of employee perks and discounts
Company
University of South Florida Libraries
The University of South Florida Libraries accelerate learning and knowledge production through distinctive collections, information service innovation, and thought leadership.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase