Kelly Achara MD, MPH
Atlanta,GA
Summary
Accomplished Senior Clinical Research Associate with over 10 years of experience leading clinical trials in cell and gene therapy (CGT), hematology, and oncology, with a focus on investigational treatments for blood cancers and genetic disorders. I have proven expertise in overseeing patient safety, ensuring data integrity, and complying with ICH-GCP guidelines, FDA regulations, and sponsor standard operating procedures (SOPs) in both early- and late-phase global studies. My skills include conducting interim monitoring visits, performing source document verification, reviewing electronic medical records (EMR), assessing adverse events (AE) and serious adverse events (SAE), managing the investigator site file (ISF), and electronic trial master file (eTMF) following the DIA model, remote monitoring, and training site staff on complex protocols.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Lead Clinical Research Associate
Bluebird bio
02.2024 - Current
- Conduct interim monitoring visits (IMVs), both on-site and remote, for Phase III pivotal trials in beta-thalassemia and cerebral adrenoleukodystrophy (CALD), ensuring compliance with protocol, ICH-GCP, and sponsor SOPs.
- Perform source document verification (SDV) against case report forms (CRFs), identifying and resolving data entry errors in EDC (Medidata Rave) and ensuring good documentation practices.
- Review electronic medical records (EMR/EHR) across Epic and Cerner systems to verify patient eligibility, concomitant medications, illnesses, and treatment timelines.
- Verify and review adverse events (AEs), serious adverse events (SAEs), and concomitant medications, ensuring accurate reporting and timely escalation per safety monitoring plans.
- Conduct Investigator Site File (ISF) and eTMF reviews, maintaining inspection readiness in alignment with the DIA Reference Model.
- Support site staff (coordinators, physicians, pharmacists) with protocol questions, data entry, and regulatory requirements, fostering strong, collaborative relationships.
- Assist in the development of trial materials, including monitoring guidelines, site tools, training guides, and CRF templates, to improve site performance and data quality.
- Contribute to the development and revision of Clinical Operations SOPs, work instructions, and templates, supporting process standardization and scalability.
- Utilize CTMS and eTMF (Veeva Vault) to track monitoring activities, site performance, and document completion.
- Identify and report protocol deviations, working with site and internal teams to implement corrective actions and prevent recurrence.
- Participate in cross-functional team meetings, providing site-level insights and operational updates to clinical, safety, and regulatory teams.
- Mentor junior CRAs in GCP, monitoring best practices, and Bluebird’s gene therapy protocols.
Senior clinical research associate
CRISPR Therapeutics
06.2022 - 02.2024
- Monitored Phase I–III trials for exagamglogene autotemcel (exa-cel) in sickle cell disease and beta-thalassemia, conducting interim and close-out visits to ensure data accuracy and GCP compliance.
- Verified source documents and EDC entries with 99% accuracy, resolving queries within 48 hours.
- Reviewed AEs, SAEs, and concomitant medications for completeness and protocol alignment.
- Maintained ISF and TMF in compliance with FDA and ISO 14155 standards.
- Trained site staff on investigational product handling, safety reporting, and EDC systems.
- Authored Clinical Study Reports (CSRs) and supported FDA regulatory submissions.
- Collaborated with central labs and imaging vendors to ensure data integration and reconciliation.
- Participated in sponsor steering committee meetings, providing site performance metrics and risk assessments.
- Supported DSMB reviews by preparing safety data summaries and ensuring timely reporting of critical events.
Clinical Research Associate
Celerion (CRO)
02.2019 - 06.2022
- Managed Phase I–III oncology and neurology trials, conducting interim monitoring visits and source verification across 25+ sites.
- Implemented risk-based monitoring (RBM) strategies, reducing protocol deviations by 30%.
- Accelerated site activation by 15% through efficient feasibility and startup processes.
- Authored CSRs and supported EMA submissions, contributing to regulatory approvals.
- Conducted EMR and EDC reviews to ensure data integrity and compliance.
Clinical Research Associate
ICON (CRO)
03.2016 - 02.2019
- Conducted site initiation and monitoring visits for oncology and CNS trials, ensuring ICH-GCP and sponsor SOP compliance.
- Verified source documents with 99% accuracy, supporting clean database locks.
- Contributed to CSRs and regulatory submissions, demonstrating strong attention to detail.
- Communicated regularly with sites to resolve queries and maintain engagement.
Clinical Study Coordinator
MD Anderson
02.2014 - 03.2016
- Coordinated Phase I–II hematologic malignancy trials, exceeding enrollment targets by 10%.
- Prepared IRB and regulatory submissions, ensuring timely approvals.
- Trained research staff on protocol procedures, EDC systems (RedCap, Epic), and safety reporting.
- Conducted source audits to ensure data accuracy and GCP compliance.
- Maintained investigator site files (ISF) and supported FDA inspections.
Education
Master of Public Health -
Emory University
Bachelor of Medicine; Bachelor of Surgery -
University of Nigeria Nsukka
Skills
- Interim Monitoring Visits (IMVs)
- ICH-GCP, FDA 21 CFR Part 11
- EDC: IBM Zelta, Medidata Rave, Oracle
- Source Document Verification (SDV)
- GCP, SOP, and Protocol Adherence
- eTMF: Veeva Vault, SharePoint
- Electronic Medical Record (EMR) Review
- Adverse Event / SAE Review & Reporting
- CTMS: OpenClinica, Medrio
- ISF & TMF Management (DIA Model)
- Concomitant Medications & Illness Review
- EHR Systems: Epic, Cerner, Meditech
- Case Report Form (CRF) Accuracy
- Protocol Deviation Management
- MS Office, Zoom, Teams
- Monitoring Guidelines & Tools
- Site Staff Support & Training
- Hematologic Malignancies: Leukemia, Lymphoma, Myeloma
- SOP & Work Instruction Development
- Research Coordinator Collaboration
- Stem Cell & Cell Gene Therapy (CGT)
- Risk-Based Monitoring (RBM)
- Physician Liaison & Communication
- Oncology: Breast, Prostate, CAR-T
- Cross-Functional Collaboration
- Remote Monitoring Best Practices
- Cardiovascular, CNS, Medical Devices
Certification
- Certified Clinical Research Professional (CCRP) – ACRP
- Good Clinical Practice (GCP) Certification
- Risk-Based Monitoring (RBM) Specialist
- Project Management Professional (PMP)®
Accomplishments
- Mentored 20+ junior CRAs, with 90% receiving promotions within 18 months.
- Published in Journal of Clinical Research Best Practices: “Risk-Based Monitoring in Global Trials”
- Speaker, 2023 DIA Annual Meeting: “Innovations in Site Oversight and Patient Recruitment”
- Recognized as 'Top CRA Leader' (2022) for operational efficiency, compliance, and team development
- Guest speaker at industry conferences on clinical trial optimization and diversity in research
Therapeutic Expertise
Hematology/Oncology: Acute Myeloid Leukemia, Lymphoma, Multiple Myeloma, Myelodysplastic Syndromes
Cell & Gene Therapy (CGT): Allogeneic Stem Cell Transplant, CAR-T, TCR Therapy, Gene-Edited Cells
Oncology: Breast Cancer, Prostate Cancer, CNS Malignancies
Medical Devices: Cardiac Implants, Ultrasound-Based Therapies
Technical Skills
- EDC Systems: IBM Zelta, Medidata Rave, Oracle Clinical, RedCap
eTMF: Veeva Vault, SharePoint
CTMS: OpenClinica, Medrio
EHR/EMR: Epic, Cerner, Meditech
Software: MS Office (Advanced), Zoom, Teams, Adobe Acrobat
Timeline
Lead Clinical Research Associate
Bluebird bio
02.2024 - Current
Senior clinical research associate
CRISPR Therapeutics
06.2022 - 02.2024
Clinical Research Associate
Celerion (CRO)
02.2019 - 06.2022
Clinical Research Associate
ICON (CRO)
03.2016 - 02.2019
Clinical Study Coordinator
MD Anderson
02.2014 - 03.2016
Master of Public Health -
Emory University
Bachelor of Medicine; Bachelor of Surgery -
University of Nigeria Nsukka
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