Clinical Research Coordinator II at University of South Florida responsible for coordinating clinical research activities and ensuring participant data quality. Serving as main contact for sponsors and patients for specific research protocols.
About the role
- Lead site qualification, initiation, monitoring and close-out for clinical studies. Ensure ICH-GCP compliance, data integrity, and support recruitment and audit readiness for Syneos Health-sponsored trials.
Responsibilities
- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; escalates serious issues and develops action plans with guidance
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
- Verifies the process of obtaining informed consent and demonstrates diligence in protecting subject/patient confidentiality
- Assesses factors affecting subject/patient safety and clinical data integrity such as protocol deviations and pharmacovigilance issues
- For the Clinical Monitoring/Site Management Plan (CMP/SMP): assesses site processes, conducts Source Document Review of site source documents and medical records, verifies required clinical data entered in CRFs is accurate and complete
- Applies query resolution techniques remotely and on site; utilizes hardware and software to support clinical project data review and capture; verifies site compliance with electronic data capture requirements
- May perform investigational product (IP) inventory, reconciliation and reviews storage and security; verifies IP dispensation and administration per protocol
- Reviews and reconciles Investigator Site File (ISF) with the Trial Master File (TMF) and ensures archiving of essential documents per local guidelines
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
- Supports subject/patient recruitment, retention and awareness strategies and enters data into tracking systems to manage observations and action items
- Manages site-level activities, communication, scope, budgets and timelines to meet project objectives; acts as liaison with project site personnel or in collaboration with other CRAs/CMA
- Ensures training and compliance of assigned sites and site team members; prepares for and attends Investigator and sponsor meetings and participates in global project meetings and clinical training
- Provides guidance towards audit readiness standards and supports audit preparation and follow-up actions
- For Real World Late Phase (Site Management Associate I business card title): supports site lifecycle from identification through close-out, chart abstraction and collaboration with sponsor affiliates and local country staff
Requirements
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
- Compliance with site-specific requests for medical or personal information for facility access (US sites) as a condition of employment
- Knowledge of local requirements for real world late phase study designs
- Chart abstraction activities and data collection experience
- Collaboration with Sponsor affiliates, medical science liaisons and local country staff
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Total Self culture and employee well-being focus
- Exposure to emerging technologies, data, science and knowledge sharing
- Diversified career paths and employment opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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