Shae Kibby
Longmont,CO
Summary
Detailed Client Service Associate known for having great organizational skills. Gifted at working with all types of customers. Looking for a new role where hard work and dedication will be highly valued.
Overview
13
13
years of professional experience
Work History
Clinical Site Manager, Clinical Research Associate
ICON Clinical Research
San Antonio, TX
11.2022 - 01.2024
- Adhered to good clinical practices, operating procedures and regulatory requirements.
- Attended investigator meetings to provide framework for successful research studies by establishing responsibilities.
- Monitored subject enrollment and tracked dropout details.
- Interacted with sponsors, CROs, investigators, vendors and subcontractors as needed.
- Reported to project manager for issues related to overall study status.
- Maintained accurate records of all regulatory submissions, correspondence and approvals received from local ethics committees or regulatory agencies.
- Established and updated site monitoring schedule and served as project head for investigational sites.
- Supported quality control program by scheduling site assessment visits for project and conducting monitoring visits.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
- Monitored safety events reported during the course of clinical trials in accordance with SOPs.
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Performed pre-study, closeout and interim visits to check on study activities.
- Evaluated proof of eligibility and consent for participants.
- Assessed incoming source documentation for accuracy and completeness against case report forms.
- Managed relationships with external vendors such as laboratory services or imaging centers.
- Ensured proper storage of investigational product at investigator sites per GCP guidelines.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Displayed strong telephone etiquette, effectively handling difficult calls.
- Promoted high customer satisfaction by resolving problems with knowledgeable and friendly service.
Country Start Up Specialist (CSSU)
Syneos Health
11.2021 - 03.2022
- Oversee site start up regulatory/IRB submissions (local and central)
- Ensure sites receive vendor access
- Apply for site IP Authorization
- IRB continuing review
- ETMF upload/maintenance
- Study regulatory/IRB continuing review and closeout submissions (central).
- Worked with cross-functional teams to achieve goals.
- Maintained open communication with team members and stakeholders, resulting in successful project outcomes.
- Identified needs of customers promptly and efficiently.
- Provided excellent service and attention to customers when face-to-face or through phone conversations.
- Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
- Promoted high customer satisfaction by resolving problems with knowledgeable and friendly service.
Site Management, Clinical Research Associate
Syneos Health
02.2020 - 11.2021
- Oversee the conduct of trials at designated sites to ensure rights and well-being of subjects are protected
- Conducts Qualification, Initiation, Interim Monitoring, and Close-Out visits, and generates contact and site visit reports in compliance with the monitoring plan
- Ensure timely and accurate access and updates of applicable trial management systems and trial master file documents
- Assesses & manages test article/study supply including supply, accountability and destruction/return status
- Maintains sound working knowledge of, and ensure compliance with ICH-GCP Guidelines, and study specific, site and CRO SOP's
- International and local regulations, Sponsor training requirements and study specific procedures, plans and training
- Actively participates in Investigator and other external or internal meetings, audits & regulatory inspections
- As required
- Follow AbbVie's distinctive hybrid monitoring approach
- Facilitate site vendor setup
- Identifying and resolving site study issues
- Ensures quality and integrity of the data, and ensures the sites are in compliance with protocol, study requirements, GCP and applicable regulatory requirements.
- Maintained strict confidentiality to keep personal information and collected data private.
- Prepared reports summarizing study progress and results for senior management review.
- Reported to project manager for issues related to overall study status.
Clinical Site Manager II (CSM)
PAREXEL International
Billerica, MA
11.2018 - 01.2020
- Oversee the conduct of trials at designated sites to ensure rights and well-being of subjects are protected
- Ensures quality and integrity of the data, and ensures the sites are in compliance with protocol, study requirements, GCP and applicable regulatory requirements
- Conducts Qualification, Initiation, Interim Monitoring, and Close-Out visits, and generates contact and site visit reports in compliance with the monitoring plan
- Ensure timely and accurate access and updates of applicable trial management systems and trial master file documents
- Assesses & manages test article/study supply including supply, accountability and destruction/return status
- Maintains sound working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL / Sponsor training requirements and study specific procedures, plans and training
- Actively participates in Investigator and other external or internal meetings, audits & regulatory inspections as required.
Clinical Site Manager I (CSM)
PAREXEL International
Billerica, MA
01.2018 - 11.2018
- Oversee the conduct of trials at designated sites to ensure rights and well-being of subjects are protected
- Ensures quality and integrity of the data, and ensures the sites are in compliance with protocol, study requirements, GCP and applicable regulatory requirements
- Conducts Qualification, Initiation, Interim Monitoring, and Close-Out visits, and generates contact and site visit reports in compliance with the monitoring plan
- Ensure timely and accurate access and updates of applicable trial management systems and trial master file documents
- Assesses & manages test article/study supply including supply, accountability and destruction/return status
- Maintains sound working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL / Sponsor training requirements and study specific procedures, plans and training
- Actively participates in Investigator and other external or internal meetings, audits & regulatory inspections as required.
Clinical Research Associate I
PAREXEL International
Tampa Bay, FL
02.2016 - 12.2017
- Perform the clinical monitoring aspect of designated projects in accordance with study specific procedures, applicable SOPs, and regulations
- Act as PAREXEL’s direct contact with assigned clinical sites and use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites
- Apply expertise and independent judgment to independently verify patient safety and patient rights
- Perform clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, and data collection)
- Collect regulatory documentation
- Ensure timely and high-quality data
- Perform qualification, initiation, monitoring, and termination of investigational sites in accordance with ICH GCP guidelines.
Director of Research, RN, CCRC
Pulmonary and Sleep of Tampa Bay
Tampa Bay, FL
12.2010 - 02.2016
- As part of the clinical research team, I have gained detailed knowledge of ICH/GCP Guidelines including an expanded level of regulatory requirements
- Experience includes working on multiple Phase II-IV clinical trials in various therapeutic areas
- This has led to obtaining extensive understanding of the clinical trial process from study qualification to close out
- Budget and Contracts
- Clinical Staff Education in regard to new protocols, and amendments as needed
- Utilize the nursing process to provide quality, evidence-based, outcome-focused care
- Ensured data integrity and proper documentation to meet all sponsor and regulatory requirements
- EDC entry via multiple EDC systems
- Patient education in regard to the clinical trial purpose, procedures, timeline for visits, and required restrictions as per protocol
- Obtained Informed Consent
- Responsible for the Investigational Product accountability, which included receiving, dispensing, and reconciliation.
- Reviewed internal reports and identified areas of risk or potential cost savings.
- Reviewed financial statements and sales or activity reports to measure productivity or goal achievement.
- Assessed employee performance against established benchmarks or targets.
- Managed staff, financials and key performance indicators to facilitate business operations.
- Supported work-life balance to improve staff morale.
- Prepared staff work schedules and assigned team members to specific duties.
- Developed policies and procedures to ensure compliance with corporate standards.
- Provided leadership, insight and mentoring to newly hired employees to supply knowledge of various company programs.
- Cultivated and maintained relationships to promote positive work culture.
- Created detailed plans outlining timelines, goals, budgets, staffing needs and other requirements for projects.
Education
Associate of Science Nursing Degree -
The Center for Allied Health and Nursing
01.2011
Skills
- Site Safety
- Multitasking and Organization
- Regulatory Compliance
- Team Leadership
- Site Inspection and Management
- Problem-Solving
- Customer Service
- Shift Scheduling
- Management
- Documentation and Reporting
- Safety Monitoring
- Conflict Resolution
- Staff Management
Languages
English
Timeline
Clinical Site Manager, Clinical Research Associate
ICON Clinical Research
11.2022 - 01.2024
Country Start Up Specialist (CSSU)
Syneos Health
11.2021 - 03.2022
Site Management, Clinical Research Associate
Syneos Health
02.2020 - 11.2021
Clinical Site Manager II (CSM)
PAREXEL International
11.2018 - 01.2020
Clinical Site Manager I (CSM)
PAREXEL International
01.2018 - 11.2018
Clinical Research Associate I
PAREXEL International
02.2016 - 12.2017
Director of Research, RN, CCRC
Pulmonary and Sleep of Tampa Bay
12.2010 - 02.2016
Associate of Science Nursing Degree -
The Center for Allied Health and Nursing
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