Idy Godfrey
Dallas,TX
Summary
Experienced Clinical Research Professional with extensive expertise in coordinating and managing clinical trials across various therapeutic areas, including Infectious Diseases and Oncology. Proficient in all phases of trial management from setup to close-out, emphasizing adherence to ICH/GCP guidelines, efficient site management, and effective cross-functional collaboration. Demonstrates a strong ability to resolve challenges and ensure study compliance, contributing to the successful execution of research objectives.
Overview
11
11
years of professional experience
Work History
Clinical Research Associate (In-House)
ICON Clinical Research Organization
Durham, North Carolina
12.2021 - Current
- Lead investigator recruitment and site management per SOPs and ICH/GCP guidelines, ensuring study and regulatory compliance.
- Resolves site/data queries and facilitates communication between project teams and study sites.
- Manages study activities across various clinical trial management systems (Veeva Vault/ODR/CTMS/eTMF/IRT).
- Manages monitoring visit reports, overseeing the escalation process to maintain study integrity.
- Oversees the Informed Consent Form (ICF) adaptation and review process.
- Facilitates cross-functional clinical study team meetings.
- Creates study-specific plans and procedural documents.
- Interacts with investigators, vendors, and subcontractors as needed.
- Draft agendas, minutes, and other meeting materials for investigator and clinical study team meetings.
- Reviews electronic data-capturing systems for data accuracy and protocol compliance.
Clinical Research Assistant
IQVIA
Durham, North Carolina
08.2020 - 11.2021
- Performed data entry, data quality checks, and query resolution in EDC.
- Assessed data for accuracy and completeness.
- Stored and maintained original source documents, CRFs, study binders, and subject binders in the document management system.
- Resolved subject laboratory queries with central laboratory and study monitors.
- Ensured that site was up-to-date with clinical trial documentations according to sponsor requirements and expectations.
- Collaborated with study monitors and clinical site team to resolve pending action-items according to sponsor and protocol guidelines.
- Earned recognition from Study monitors, CRO managers and Clinical Site Team for timely data-lock readiness.
Clinical Research Coordinator
Innovative Clinical Research Institute
Whittier, California
02.2019 - 07.2020
- Identified potential clinical trial subjects using study protocol inclusion and exclusion criteria.
- Discussed details of investigative product/device and protocol procedures with patients and attending oncologist.
- Collaborated with the clinical trial team to facilitate subject randomization and enrollment.
- Escalated and discussed unique subject eligibility with study monitors, medical liaisons, and medical monitors.
- Participated in site initiation visits and interim monitoring visits.
- Instrumental in achieving a 55% increase in clinical trial subject enrollment.
Medical Coder & Biller
Santa Fe Medical Clinic
Carson, California
08.2016 - 09.2016
- Performed coding of medical services using CPT and ICD codes.
- Generated medical claims and billed medical insurances for medical services.
- Investigated and resolved billing discrepancies with medical insurance providers.
- Communicated reimbursements with medical provider.
- Processed 80% of medical insurance and personal injury claims.
- Prevented losses by ensuring timely billing for medical services within allocated billing period.
Medical Office Manager
Santa Fe Medical Clinic
Carson, California
09.2013 - 12.2015
- Managed and supervised daily clinic operations.
- Supervised, trained, and evaluated medical office assistants.
- Coordinated the flow of services between medical providers.
- Ensured clinic operations followed policies and procedures.
- Supervised vaccine and medication inventory ensuring appropriate storage and accountability.
- Managed office inventory, budgets, insurance billing, expenditures, remittances, and profits.
- Instrumental in getting the medical clinic approved for Medicaid, Medicare, Insurance IPA, and other federal funded programs.
- Increased profits by ensuring timely billing and remittance for medical services.
Education
M.D. - Medicine
Windsor University School of Medicine
Saint Kitts And Nevis01.2011
Pre-Medicine - Medicine
All Saints University School of Medicine
Commonwealth Of Dominica09.2007
Skills
- Clinical Trial Management
- Protocol Development and Adherence
- Regulatory Compliance (FDA/ICH/GCP)
- Data Collection and Evaluation
- Interdepartmental Collaboration
- Clinical Site Management
- Clinical Documentation
- IRB/Ethics Committee Submissions
- Independent Data Monitoring Committee (IDMC)
- Clinical Trial Management Systems (Veeva Vault/CTMS)
- Trial Master File (TMF/ISF)
- Monitoring Visit Reports
- Inspection Readiness
- Source Document Verification
- Informed Consent Process
- Electronic Data Capture (EDC)
- Case Report Forms
Therapeutic Areas
- Infectious Diseases: COVID 19 Vaccine.
- Oncology: Cutaneous Squamous Cell Carcinoma (CSCC), Basal Cell Carcinoma (BCC), Non Small Cell Lung Carcinoma, Gallbladder, Skin, Cholangiocarcinoma, Head & Neck, Breast, Esophageal, Colorectal, Renal, and Ovarian.
- Hematology: B-Cell Non Hodgkin's Lymphomas, Sickle Cell, Multiple Myeloma, Myelofibrosis, and Polycythemia Vera.
- Other: Stomatitis and Hand & Foot syndrome.
Vendor and System Experience
- Central Laboratory Services: ICON, Q2, and PPD.
- Clinical Data Monitoring and Management: REDCap, ICOTrial, CTMS, TRACK (TMF), QMOD, RIM, Veeva Vault, ODR, QUMAS, SharePoint, Adobe, COMPASS, Microsoft word, Power point, and Excel.
- Clinical Research Organizations (CRO): ICON, PRA, Syneos Health, and IQVIA.
- Electronic Data Capture (EDC): iMedidata Rave and Veeva.
- Homecare Support: Symphony Health.
- Investigator & Research Services: Box, Source Drive, Greenphire, StudyHub, and Firecrest.
- IXRS/IRT: Calyx and YPrime.
- Photography and Imaging: Canfield Clinical Services.
Accomplishments
- Facilitated study-level protocol deviation review processes on sponsor protocols to ensure oversight and compliance with regulatory authorities and sponsor departmental SOPs.
- Executed more than six (6) key study-level document upgrade on sponsor protocols.
- Led site-level study activation efforts from site selection to activation.
- Achieved 98% accuracy goal for study-level Inspection Readiness Review process on sponsor protocols.
- Successfully implemented upgrades to study-level manuals, plans, and other key documents for the execution of sponsor protocol amendment within project timelines.
- Organized multiple sponsor Investigator Calls including scheduling, presentation drafting, attendance log, and minute summarization.
- Received recognition from upper management, managers, study leads, and colleagues which resulted in financial reward for outstanding performance.
- Earned study team recognition for leading efforts in the institution of Independent Data Committee (IDMC) set-up within timelines.
Languages
English
Native/ Bilingual
Ibibio
Native/ Bilingual
Publications
- Abstract:
Cigarette smoking and alcohol use among mauritian adolescents:Analysis of 2017 WHO global school-based health survey (GSHS)., Basiru,T., Adereti, I., Olanipekun, A., Nwoye, I., Anugwom, G., and Agbator, R., Abstract presentation at American Public Health Association (APHA) Annual Meeting and Expo, 2021
- Publication:
Do Cigarette Smoking and Amphetamine Use Predict Suicide Behaviors Among Adolescents in Liberia? Findings from a
National Cross-sectional Survey., Basiru,T., Adereti, I., Umudi, O., Ezeokoli, A., Nwoye, I., and Hardy, O., https://link.springer.com/article/10.1007/s11469-022-00867-1, 2022
Timeline
Clinical Research Associate (In-House)
ICON Clinical Research Organization
12.2021 - Current
Clinical Research Assistant
IQVIA
08.2020 - 11.2021
Clinical Research Coordinator
Innovative Clinical Research Institute
02.2019 - 07.2020
Medical Coder & Biller
Santa Fe Medical Clinic
08.2016 - 09.2016
Medical Office Manager
Santa Fe Medical Clinic
09.2013 - 12.2015
M.D. - Medicine
Windsor University School of Medicine
Pre-Medicine - Medicine
All Saints University School of Medicine
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