Alysha Siman
Boynton Beach,FL
Summary
Clinical Operations Professional Highly skilled and experienced professional with over a decade of experience in clinical operations, specializing in site management and clinical quality management. Demonstrated expertise in adhering to GCP and other regulatory authority guidelines. Recognized as a Subject Matter Expert (SME) in two global projects. Proven track record in inspection and audit activities, with a strong focus on creative problem-solving and proactive leadership. Consistently exceeds expectations, acknowledged as an expert by peers and stakeholders. Possesses a strong commitment to excellence, seeks new developmental challenges.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Quality and Training Advisor 2
ICON
Raleigh, United States of America
08.2022 - Current
- Identify process gaps and implement process and efficiency improvements
- Conduct Clinical Supply Investigations with uCRA/CRA
- Develop, conduct, and improve training on new procedures, processes, and systems for existing staff
- Support field team in preparing for external audits
- Coordinate and host regular continuing education and development opportunities for staff
- Provide compliance support by answering questions and offering advice on ICH/GCP, SOPs, and local regulations and guidelines
- Conduct trending analyses on data collected through QC activities and identify potential training needs
Quality & Training Advisor 1
ICON
Raleigh, United States of America
07.2021 - 08.2022
- Works collaboratively with the Site Monitoring Management (SMM) to recognize local trends and execute root-cause analysis and develop action plans
- Conducts QC evaluations to assess compliance within study management
- Disseminates information and provides training for Clinical Research Associate (CRA) Managers, Project Managers, CRAs, and Clinical Trial Coordinators (CTCs)
- Communicates quality and compliance issues and trends to SMM and Leadership, while overseeing the implementation of the In House Quality Control Plan (IHQCP)
- Provides training for Managers, Clinical Research Associates, and Clinical Trial Coordinators to ensure adherence to quality and compliance standards
Clinical Research Associate III
ICON
Raleigh, United States of America
07.2019 - 07.2021
- Company Overview: formerly PRA Health Sciences
- Acts as a local resource to meet Shared Investigator Platform goals and provides support for vendors and query resolution
- Collaborates with clinical research directors, managers, operations managers, trial coordinators, medical directors, quality managers, and site relations managers to ensure effective clinical trial management and compliance with regulations
- Undertakes responsibility as a Lead Dedicated Share Investigator Platform (SIP) CRA and SME, collaborating with the US SIP Implementation Lead and engaging Clinical Research Managers to involve in new studies
- Conducts onboarding and training for new Dedicated SIP CRAS, facilitates Facility and Site User onboarding, SIP training, and communications, and offers support to Sponsor Users
- Coordinates virtual meetings to understand institutional structure and identify key managers within the Shared Investigator Platform (SIP)
- Implements and monitors clinical trials to ensure adherence to regulatory requirements and ICH-GCP guidelines, including verification of collected data and reporting of Serious Adverse Events (SAE)
- Assesses and initiates clinical trials at investigative sites, provides training, escalates issues, and ensures compliance with protocol and study requirements
- Establishes regular communication with clinical investigators, administers protocol training, and resolves any outstanding issues effectively
- Acts as a resource for new employees and facilitates the timely resolution of trial and clinical issues
- Ensures all required training is completed and documented and supports the resolution of outstanding items with the Help Desk
Clinical Research Associate II
ICON
Raleigh, United States of America
04.2016 - 07.2019
- Company Overview: formerly PRA Health Sciences
- Implemented and monitored clinical trials to ensure compliance with regulatory requirements and ICH-GCP guidelines, ensuring sponsor and investigator obligations were met
- Reviewed and verified the accuracy of clinical trial data, both onsite and remotely, and ensured reporting of Serious Adverse Events (SAE) in accordance with trial specifications and ICH-GCP guidelines
- Collaborated with various healthcare professionals and stakeholders, including Clinical Research Directors, Managers, Associates, Operations Managers, Global Clinical Trial Operation, and Quality Managers, to support the successful execution of clinical trials
- Worked with Clinical Research Associates to meet recruitment requirements through Webex meetings and onsite visits
- Functioned independently with minimal oversight, serving as a resource for new employees and ensuring all necessary training was completed and documented
- Communicated with investigative sites, performed source document verification, and facilitated the resolution of trial-related issues
- Assessed the qualification of potential investigative sites, initiated and closed clinical trials, and provided regular site status information to team members and trial management
- Developed innovative approaches for site recruitment, selection, and initiation activities, while maintaining a focus on compliance and accountability at investigative sites
Clinical Research Associate III
Clinical Research Management, INC.
Frederick, United States of America
02.2012 - 03.2016
- Assessed Investigational Product (IP) accountability, dispensation, and compliance at investigative sites
- Conducted essential document site file reconciliation and performed source document review, verification, and query resolution
- Verified Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines
- Ensured completion and documentation of all required training
- Implemented and monitored clinical trials to ensure compliance with local regulatory requirements and ICH-GCP guidelines, developing and implementing innovative approaches for site recruitment, selection, and initiation activities
- Reviewed and verified the accuracy of clinical trial data, both onsite and remotely
- Initiated and closed clinical trials at investigative sites, provided training on proper conduct of trials, and communicated regularly with investigative sites
- Functioned independently with minimal oversight, serving as a resource for new employees
- Updated applicable tracking systems, completed monitoring activity documents, and worked closely with the clinical team to resolve trial and clinical issues
- Escalated site and trial related issues as per SOPs until resolved, and provided regular site status information to team members and trial management
Registered Nurse
Northwest Medical Center
Margate, United States of America
01.2007 - 02.2012
- Received and assessed patients post-operatively, performed physical exams, and obtained health histories
- Provided interventions such as titrating vasoactive medications and assisted with ventilator management and weaning
- Communicated clearly and timely with Surgeons/Physicians regarding patient updates and new orders
- Prepared and administered prescribed medications, and educated patients about potential adverse effects and side effects
- Monitored and adjusted specialized equipment used on patients, interpreted and recorded electronic displays, central venous pressures, pulmonary artery pressures, and cardiac rhythms
- Recorded all care information concisely, accurately, and completely in a timely manner
- Advocated for patient safety and educated patients on what to expect during surgery and the recovery period
- Supervised and coordinated care for patients in multiple units and responded to life-saving situations based on nursing standards, policies, procedures, and protocols
- Ordered and evaluated diagnostic tests, interpreted patient information, and made critical decisions about necessary actions
- Administered wound care and other personalized interventions
- Applied Hemodynamic, Phlebotomy, and IV protocols
- Provided health promotion counseling and education
- Made beds, bathed, and fed patients
Education
Undergraduate, Bachelor of Science - Nursing
Capella University
Minneapolis, MN, United States of America03.2020
Undergraduate - Nursing
Broward College
Coconut Creek, Florida, United States of America05.2006
Skills
- Quality Management System Compliance
- Regulatory Compliance
- Inspections and audits
- Problem-solving abilities
- Teamwork and Collaboration
- Leadership
- Continuous Improvement
Certification
Registered Nurse, Florida Nursing board, United States of America (the) Acquired Date: May 2006 Expiration Date: 31Jul2026
Accomplishments
- 04Jan2023 ICON Inspire Award for Global eTMF training initiative
- 29Jun2023 ICON Inspire Award for US Country Ops audit - Going the extra mile
- 27Jun2023 ICON Inspire Award for Collaboration and agility
- 01Jan2024 Co-authored an article providing an overview of audits and their impact on enhancing compliance, driving quality, and fostering continuous improvement. Published in the GCTO Newsletter 1Q2024, reaching a diverse readership.
- SIP Point of Contact Study Support CRA Lead Recruitment CRA Dedicated SIP CRA
- Lead Dedicated SIP CRA
- SIP Point of Contact Study Support CRA
- Recruitment and Retention Subject Matter Expert (SME), Lead Recruitment CRA- Led recruitment initiative which increased enrollment.
- Recruitment and Retention SME Dedicated SIP CRA
- Lead Dedicated SIP CRA- Responsible for new trial SIP readiness. Conducts trainings for CRAs, Site staff and Research Managers
- Leading by Example Award- Recognized for a high standard of excellence in support of the Site Investigator Platform Initiative.
- Lead Recruitment CRA Study Support CRA
- Recruitment and Retention SME
System Experience
- Clinical Trial Management Systems: Medidata CTMS, SMART (Amgen)
- EDC: Datalabs, Exco InTouch, Oracle Inform, Veeva Vault EDC
- IVRS/IWRS/RTSM: Almac, Cenduit, ClinPhone IVRS
- Reporting & Analysis: Spotfire
- TMF: Veeva Vault ETMF
Vendor Experience
- Central ECG & BP Monitoring: BioTelemetry, BioTelemetry
- Central Lab Services: Covance, PPD
- EDC/eDiary/e-PRO: InForm 6.1, Exco InTouch, SMART, ERT Study Works
- IRB: Copernicus Group, WIRB, Advarra
- Other: Signant Health eCOA, Cognizant
Protocol therapeutic Experience
Cardio-Metabolic Diseases, phase III
Genitourinary phase IIIB
Respiratory phase IIIB
Vaccine phase III
Timeline
Quality and Training Advisor 2
ICON
08.2022 - Current
Quality & Training Advisor 1
ICON
07.2021 - 08.2022
Clinical Research Associate III
ICON
07.2019 - 07.2021
Clinical Research Associate II
ICON
04.2016 - 07.2019
Clinical Research Associate III
Clinical Research Management, INC.
02.2012 - 03.2016
Registered Nurse
Northwest Medical Center
01.2007 - 02.2012
Undergraduate, Bachelor of Science - Nursing
Capella University
Undergraduate - Nursing
Broward College