Sally Acosta
Covington
Summary
Creative eSource Designer known for high productivity and efficient task completion. Specializing in eSource design, meeting ease of user experience, high-quality clinical research source document creation & quality review. Excels in problem-solving, communication, and teamwork to deliver quality eSource that meets sponsor needs & company SOPs.
Overview
15
15
years of professional experience
Work History
E-Source Designer
Velocity Clinical Research
Covington
05.2020 - Current
- Developed e-Source design implementation within Crio Research IO program utilizing study protocols and guidelines to create easy to follow, accurate clinical research source.
- Facilitated implementation of e-source systems during company transition to digital tools.
- Created and maintained over 300 study builds with theassistance of computer programs (Crio) in 2021-2022.
- Consulted with study sponsors and team manager to identify design requirements for each project.
- Conducted research to develop comprehensive project concepts and strategies.
- Maintained e-source design knowledge by attending various workshops, professional society gatherings, and meetings.
- Ensured consistent use of graphic imagery in materials and marketing outreach to enhance study recruitment.
- Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
- Executed daily responsibilities with precision and attention to detail.
- Executed duties following established standards, policies, and regulatory guidelines.
- Successfully managed tasks under tight deadlines in a high-pressure environment.
- Applied critical thinking skills to analyze problems and assess effective solutions.
- Developed and maintained courteous and effective working relationships.
- Created and provided multiple study sites with Excel trackers to implement the organization of subjects and ensure subject compliance
- Reviewed charting and study compliance for multiple study sites for quality assurance.
- Managed study portals, responded to inquiries, and ensured accurate data entry.
CRA
Medpharmics LLC
Covington
04.2015 - 05.2021
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Conducted site qualification, initiation, interim monitoring, and close-out visits at investigative sites to uphold regulatory compliance.
- Coordinated protocol-related visits and testing to ensure patient safety, protocol compliance, and high data quality.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Maintained site monitoring schedules to facilitate effective communication with members of the clinical team.
- Submitted routine study compliance reports and follow-up letters to facilitate internal and external communication.
- Provided clinicians with data to conduct clinical trials and determine methods to prevent, screen for, diagnose and treat disease.
- Created and maintained database and records filing system to document data on specimen collection, processing and storage.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
- Reviewed clinical data, source documentation, case report forms, and regulatory files to ensure accuracy and completeness.
- Conducted site qualification meetings with sponsor representatives to discuss clinical study developments.
- Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
- Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
- Applied extensive study source and e-source knowledge to troubleshoot and resolve regulatory document issues.
- Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
- Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
- Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
Licensed Midwife
Self-employeed
Covington
01.2011 - 04.2020
- Assisted in over 200 successful births and provided postpartum counseling for struggling families to increase happiness and health of newborns and mothers.
- Coached over 200 women through the final stage of labor and delivered over 200 newborns in family-oriented settings.
- Handled labor and delivery for moms choosing alternative birth methods.
- Performed prenatal and postnatal examinations.
- Offered primary care to expecting mothers and newborn infants.
- Assisted mothers with breastfeeding, self-care and postpartum healthcare.
- Provided emotional support to expecting mothers by addressing questions and alleviating concerns, fostering a positive birthing experience.
- Participated in advanced practice training and worked alongside physicians.
- Performed low-intervention techniques to induce labor or relieve pain during labor.
- Diagnosed and treated patients with high-risk complications.
- Educated families on benefits of breastfeeding, emphasizing proper positioning, latching, and breast care techniques to support successful breastfeeding.
- Met with mothers to design individualized birth plans in terms of health concerns, birthing desires and potential problems.
- Provided healthcare information and educational resources to new parents.
- Guided parents and newborns to physicians while maintaining calm and providing reassurance regarding health conditions and test results.
- Informed families on potential risks and overall benefits of different birth options.
Education
ACRP-Certified Research Professional - Clinical Research
ACRP
Online04.2023
Associate of Applied Science - Obstetrics
Birthingway College of Midwifery
Portland, OR11-2008
Certified Medical Assistant & Phlebotomist - Patient Care
Nick Randazzo's Vocational Institute
New Orleans, LA01-2000
Skills
- e-Source design
- Research center startup
- Developing study tools
- Subject tracking tools
- Regulatory document completion
- Protocol adherence
- Data Collection
- Study adherence
- Clinical research
- Data management
- Regulatory compliance
- Quality assurance
- Patient recruitment
- Site operations coordination
- Trial methodologies
- Pre-study visits
- Investigator meetings
- Team collaboration
- Effective communication
Timeline
E-Source Designer
Velocity Clinical Research
05.2020 - Current
CRA
Medpharmics LLC
04.2015 - 05.2021
Licensed Midwife
Self-employeed
01.2011 - 04.2020
ACRP-Certified Research Professional - Clinical Research
ACRP
Associate of Applied Science - Obstetrics
Birthingway College of Midwifery
Certified Medical Assistant & Phlebotomist - Patient Care
Nick Randazzo's Vocational Institute