Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) 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; immediately communicates/escalates serious issues to the project team and with guidance develops action plans

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Provide administrative support to the Safety and Pharmacovigilance department while adhering to all data protection guidelines, Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines, and study procedures.

The Center for Urban Affairs and Community Services can provide research assistance in the broad areas of social sciences, education, human services, policy analysis, and program evaluation and makes use of the full range of knowledge and expertise of the University community as a whole. The Center can carry out research projects or provide technical assistance in any aspect of project management, design, or operation.

Establish and maintain safety case files through the entire studylifecycle.  Ensure supporting case documentation is printed from clinicaldatabase or received, saved electronically and filed into theindividual safety case file provided to the Safety Lead.  Monitor the electronic Safety mailbox, to receive documents,and disseminate case information to the Safety Lead for triageand assessment of the safety report.  Perform data entry of case information into the safety database.  Work with Safety Leads to create, distribute, and track investigator notification letters and IRB/EC notifications asrequired by government regulations.  Assists with the processing of safety cases. Identify missing/discrepant data (medical and documentation issues), write standard queries for missing or inconsistent data,address queries with site personnel and/or reporter, evaluatequery responses, and resolve queries when complete.  Reconcile safety data with applicable sources.

• Independently manage all follow-up study operations and supervise a call center of up to 32 staff. Manage the staff by developing project work instructions and extensive training on research best practices for telephone interviewing. • Draft and finalize study documents, data collection strategies, and monitoring systems to guarantee data is accurate and complete. Prepare and submit documents to IRB and SAB to safeguard participants’ rights. • Developed and managed a pilot study to determine best marketing strategy for cohort participation. Supervised agreed upon outreach plan, which in turn increased follow-up interview participation by 15%.

• Assist with the development and implementation of study documents, data collection, and monitoring systems.• Maintain progress reports, tasks lists and central study files.

• Maintained clinical records by managing insurance claims and determine client benefits, enabling the client to receive the maximum benefit based on their coverage.

• Organized and supervised service projects, college tours, and meetings for the Youth Leadership Institute as part of the Mentor Advocate curriculum which supported youth by giving them career and college exposure. • Conducted a research based process evaluation of Blue Ribbon’s College and Career Curriculum which helped the program fill in participation gaps and better meet the needs of the participating youth and their families.

• Monitored foster care families to certify that best practice standards were being upheld and that the child was thriving in their environment. • Conducted research on policies, procedures, resources and grants for the purpose of continuing education for the foster care departments across central North Carolina, which in turn would lead to community improvement.

• Collaborated to establish daily Track-Out, After-school, and Summer Camp programs for the Lake Lynn Community Center, serving youth enrolled in the parks and rec program. Developed a structured environment for children to thrive through daily programs, field trips, and safety standards, all staying within a program budget.• Supervised up to 12 counselors and 50 campers, as well as communicated with parents and patrons on a regular basis to promote program growth and advocate for the city as an ambassador.

• Plan, execute, and supervise daily schedules, field trips, clinics, activities and promotions for elementary and middle school based programs year round.• Assist with the organization and implementation of the annual We Build People Campaign as well as act as the campaigns videographer/photographer.