Ginger Bliss, Rn, Bsn, Ccrc Email & Phone Number

Orlando, Fl, Us

United States

New York, United States

- Manage decentralized clinical trials within a Virtual Research Organization while adhering to regulatory requirements, GCP guidelines, and SOPs. - Conduct virtual visits for site qualification and initiation, monitoring, adverse event reporting, and site close-out. - Handle regulatory, IRB, and IEC documentation, IND safety letter distribution, and confidentiality disclosure agreements.- Train new hires on recently adopted platform and tracking system and oversee collaborative effort to screen 2,000+ prospects with over 400 enrolled to date.- Streamlined screening studies of up to 600 participants by creating scripts and checklists to assist in vetting and corresponding with individuals. - Facilitate study for infant formula trial involving seven virtual calls in four months to walk participants through measurements and discuss concerns.- Improved retention utilizing chat, email, and SMS and conducting virtual calls via Zoom to educate on timelines, requirements, and clinical research.- Identified and resolved pattern of reduced engagement by conducting outreach efforts to remind of upcoming visits and sending automated reminders.- Promote data integrity by leveraging Electronic Data Capture (EDC) systems and electronic Patient Reported Outcome (ePRO) tools.- Drive QA by reviewing study-related documents, resolving audit findings, performing QU of electronic data feeds, and utilizing data management tools.

Orlando, Florida, United States

- Served as first in role to establish organizational processes and protocols for efficient clinical trial operations. - Oversaw research sites, maintained compliance with ICH-GCP guidelines throughout study lifecycle, and ensured SOPs were maintained. - Conducted internal audits, site initiation visits, and investigator meetings.- Created Research 101, SOPs, and overview of key medical terms and processes from scratch to streamline training.- Developed visual worksheets and checklists for newly assigned studies, along with source documents to be used during study visits. - Conducted data reviews in EMR to identify prospective participants, established recruitment and retention plans, and educated on ALCOA principles.- Facilitated start-up activities by conducting participant visits.

Orlando, Florida Area

Shreveport, Louisiana, United States

Provided specialized care to premature and critically ill newborns. Assessed, monitored and managed complex medical needs. Administered treatments, supported families and collaborated with multidisciplinary teams to ensure optimal patient outcomes.