Shanterria Nance
Frisco,TX
Summary
Experienced and adept Senior Site Activation Specialist with 6 years of clinical research being versed in several phases of the many therapeutic areas. Keenly overseeing the start-up, maintenance, and close-out phases(s) during clinical trials to support country/site specific activities. Effectively incorporating cross-functional collaboration skills with internal and external study teams to achieve project objectives while delivering on-time results. Strong management capabilities to contribute to the success of clinical trials while pursuing professional growth and development within the organization
Overview
10
10
years of professional experience
Work History
Senior Site Activation Specialist
Worldwide Clinical Trials
2021.05 - Current
- Streamline site activation by effectively managing country-specific activities resulting in a significant reduction in site activation time and study initiation
- Support feasibility of assigned countries by assisting with site identification outreach, CDA collection and FQ completion
- Consistently achieve superior trial execution by effectively collaborating with internal/external team members to plan and lead assigned clinical trials
- Generate and review management reports
- Serve as the primary point of contact for assigned studies providing guidance and support during the activation process
- Improve study tracking efficiency by enabling more effective resource allocation
- Maintain compliance with SOPs, GCP, and FDA regulations
- Assist in the development of informed consents and internal documents as needed
- Maintain current knowledge of FDA directives, regulations, and GCP guidelines minimizing regulatory errors to enhance study validity
- Working knowledge of internal SOP's and regulatory compliance
- Upload documents to the specified TMF(s)
- Attend weekly internal meetings and daily Sponsor meetings
- Work with internal team to identify and evaluate fundamental issues on assigned projects to ensure solutions are implemented
- Experience with budget development, negotiation, forecasting, and finance processes
Clinical Trial Specialist II
United BioSource Corporation
2020.02 - 2021.05
- Accelerated study start-up, maintenance, and close-out by serving as the primary site management contact
- Identified potential sites in research effort, performing various start-up activities for sure readiness: collecting regulatory documents, supported contract & budget team, trained sites to collect data & safety data reporting, managed site activities during maintenance, and closed down research activities at sites once assigned study concluded
- Assisted in organizing and preparing meetings
- Served as a primary point of contact for sites to provide guidance and support throughout the activation process
- Conducted remote pre-study visits and site initiation visits
- Ensured assigned studies were audit-ready through the compilation of regulatory documents for TMF filing
- Collaborated with the study team daily
Clinical Trial Specialist
PRA Health Sciences
2019.01 - 2020.02
- Focused on site management activities and adeptly managed regulatory and IRB activities
- Enhanced project transparency through the tracking of milestones, generating study metrics, and providing regular updates to management
- Contributed to an increase in project efficiency and informed decision-making
- Remained focused on timely filing of documents in TMF and strict adherence to FDA directives and regulations
- Focused on compliance-related issues
- Rolled out trainings to internal team and clinical site staff
- Organized meeting agenda, scheduled meetings, and completed meeting minutes
Certified Medical Assistant
St. Luke's Primary Care
2015.02 - 2018.09
- Focused on enhancing patient care and quality by assisting all medical personnel with effectively delivering professional medical care
- Consistently provided exceptional customer service with a professional demeanor, contributing to an improvement in overall patient experience and fostering trust among clientele
- Adhered to HIPAA standards and maintained patient confidentiality to ensure a secure healthcare environment, resulting in a reduction in privacy violations
- Prioritized these responsibilities while upholding high patient care and organizational excellence standards
Education
Bachelor of Science - Environmental Policy and Management
Purdue Global University
09.2018
Associate of Science - Healthcare
Moultrie Technical College
09.2004
High School Diploma - Business
Worth Co. High School
05.2001
Skills
- Team Collaboration
- Project Management
- Regulatory Compliance
- Site Activation & Study Tracking
- Communication & Problem-solving Skills
- Presentation skills
- Organizational and Time Management Skills
- Ability to work with little or no supervision
- Professionalism, confidence, and ethical standards
- Proficient in MS Office (Word, Excel, PowerPoint)
- Knowledgeable of CTMS & EDC System
- Knowledge of GxP Regulations, ICH Guidelines, 21 CFR Part 11, and HIPAA
Timeline
Senior Site Activation Specialist
Worldwide Clinical Trials
2021.05 - Current
Clinical Trial Specialist II
United BioSource Corporation
2020.02 - 2021.05
Clinical Trial Specialist
PRA Health Sciences
2019.01 - 2020.02
Certified Medical Assistant
St. Luke's Primary Care
2015.02 - 2018.09
Bachelor of Science - Environmental Policy and Management
Purdue Global University
Associate of Science - Healthcare
Moultrie Technical College
High School Diploma - Business
Worth Co. High School
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