Alex Hall
Boulder,CO
Summary
Accomplished Clinical Research Associate with 2 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
Advanced Clinical
02.2023 - Current
- Conducts site qualification, initiation, interim, and close-out visits, ensuring compliance with ICH/GCP guidelines
- Conducts Source Data Verification (SDV) to ensure the accuracy and completeness of data recorded in electronic Case Report Forms (eCRFs), maintaining compliance with protocol and regulatory requirements
- Performs comprehensive investigational product (IP) drug accountability checks to ensure compliance with protocols, including verifying proper storage conditions, accurate dispensing, and timely returns
- Ensures accurate documentation, timely reporting, and resolution of protocol deviations in compliance with regulatory requirements and study guidelines
- Develops comprehensive monitoring visit reports (MVRs) that effectively summarize key findings, action items, and follow-up tasks, ensuring resolution of site-specific issues after each visit
- Ensures data accuracy and integrity by proactively identifying, tracking, and resolving data discrepancies and queries
Senior Clinical Trial Associate
Advanced Clinical
02.2022 - 02.2023
- Acts as a key liaison between clinical sites and the project management team, ensuring seamless communication, coordination, and collaboration to drive project success
- Provides mentorship to new employees, conducts engaging training sessions, and ensures adherence to company policies and procedures
- Supports CRAs in all aspects of site monitoring activities, including comprehensive pre-visit preparations, documentation during visits, and efficient post-visit follow-ups to ensure compliance and study progression
- Oversees the management and maintenance of the eTMF, guaranteeing all essential documentation is complete, accurate, and compliant with audit readiness standards
- Ensures effective coordination and oversight of multiple vendors to guarantee timely delivery of study materials and services, as well as study staff access
- Generate and distribute study status reports, tracking site performance, enrollment progress, and data quality
Project Specialist
Syneos Health
02.2020 - 02.2022
- Prepares and distributes detailed agendas, meeting minutes, and follow-up actions for internal and external stakeholders, ensuring clarity and alignment on project goals
- Supports quality assurance activities, including audit preparation, internal reviews, and ensures timely resolution of actionable issues
- Manages participant recruitment, enrollment, and tracking to ensure adherence to study protocols, improving efficiency and reducing delays in enrollment
- Oversees data collection, monitoring, and reporting, ensuring data accuracy and integrity, and generating key performance metrics for project reporting
- Identifies, documents, and resolves project risks and issues, implementing corrective actions to maintain project integrity and timelines
- Develops and maintains training materials and standard operating procedures (SOPs) to ensure staff adherence to established protocols
Project Assistant
PPD
08.2019 - 02.2020
- Schedules and manages logistics for project team meetings such as investigator meetings, site initiation visits, and regular project status updates to ensure timely and effective communication
- Assists in the preparation and distribution of study-related documentation, including protocols, informed consent forms, case report forms (CRFs), and other essential study documents
- Maintains project calendars, tracking key milestones, deadlines, and team availability to ensure timely completion of tasks
- Collects, reviews, and organizes essential study documents, ensuring accuracy and completeness before filing
Education
Bachelor - Exercise and Sports Science, Business Administration
Texas State University
San Marcos, TX12.2019
Skills
- Site monitoring
- Report writing
- Vendor Management
- Reviewing data standards
- Essential document review
- Coordinating supplies
- Protocol adherence
- Regulatory submissions
- Informed Consent process
- ICH-GCP guidelines
- Interdepartmental collaboration
- Electronic Data systems
Therapeutic Areas Of Expertise
- Oncology/Advanced Solid Tumors, I-III, 2 years, USA, CAN, Monitoring, IHCRA
- Hematology/Sickle Cell Disease, III, 2 years, USA, Monitoring, IHCRA
- Oncology/Breast Cancer, I/II, 1 year, USA, CAN, Monitoring, IHCRA
- Obesity, II, 1.5 years, USA, GSSU & Monitoring, IHCRA
- Autoimmune/Pemphigus Vulgaris, I/II, 0.5 years, USA, GSSU & Monitoring, IHCRA
- Sleep/Idiopathic Hypersomnia, III, 0.5 years, USA, CAN, GSSU & Monitoring, IHCRA
Certification
- Good Clinical Practice (GCP) Certification - Various Providers.
- Human Subjects Protection Certificate– CITI Program or Other Recognized Bodies.
- IATA Shipping and Transport of Dangerous Goods Certification – International Air Transport Association.
Timeline
Clinical Research Associate
Advanced Clinical
02.2023 - Current
Senior Clinical Trial Associate
Advanced Clinical
02.2022 - 02.2023
Project Specialist
Syneos Health
02.2020 - 02.2022
Project Assistant
PPD
08.2019 - 02.2020
Bachelor - Exercise and Sports Science, Business Administration
Texas State University
Similar Profiles
Brittany Holloway, MSN, RNBrittany Holloway, MSN, RN
Senior Clinical Research Associate at Advanced ClinicalSenior Clinical Research Associate at Advanced Clinical
Fatima AlmohammadFatima Almohammad
Medical Assistant/ Phlebotomy/EKG Technician at Advanced ClinicalMedical Assistant/ Phlebotomy/EKG Technician at Advanced Clinical
Chun M. Ng, PharmD.Chun M. Ng, PharmD.
Global PV Harmonization and Optimization Associate at Advanced ClinicalGlobal PV Harmonization and Optimization Associate at Advanced Clinical