Somadina Nwaokafor
Atlanta,USA
Summary
Senior Clinical Research Associate (Sr. CRA) with extensive experience overseeing Phase I–III clinical trials and Class I–IV and post-market medical device studies. Proven expertise across multiple therapeutic areas including Oncology, CNS, Cardiology, Infectious Disease, Rare Disease, Pain Management, and Respiratory, as well as IVD (Point-of-Care), Cardiology, and GI medical devices. Known for strong site oversight, regulatory compliance, and cross-functional collaboration. Seeking a long-term opportunity with a CRO or Sponsor that values operational excellence and continued professional growth.
Overview
9
9
years of professional experience
Work History
SENIOR CLINICAL RESEARCH ASSOCIATE (CONSULTANT)
CATALYST
Atlanta
11.2021 - Current
- Evaluated proof of eligibility and consent for study participants during the recruitment process.
- Performed source data verification and followed up on data queries at site level, reviewed risk-based monitoring information to enhance data quality and optimize frequency of site visits
- Utilized RBM techniques to identify highest risk patients based on provided data
- REVIEW THE STATUS AND CONTENTS OF ESSENTIAL DOCUMENTS AT THE SITE LEVEL AND RECONCILE STUDY ISF/TMF AT SITE AND/OR COUNTRY LEVEL
- Reviewed pathology reports and diagnostic outcomes related to medical imaging in oncology to ensure accuracy and compliance
- PERFORM DEVICE/IP ACCOUNTABILITY ON BACK-LOGGED SITES, ON-SITE, AS WELL AS REMOTELY
- ATTEND SITE CLIA WAIVED IVD EQUIPMENT TRAINING
SENIOR CLINICAL RESEARCH ASSOCIATE (CONSULTANT)
OXFORD GLOBAL RESOURCES
05.2022 - 02.2024
- CRA ON A COMPLEX CLINICAL TRIAL INVOLVING IMPELLA SUPPORTED PCI IN HIGH-RISK PATIENTS WITH COMPLEX CORONARY ARTERY DISEASE AND REDUCED LEFT VENTRICULAR FUNCTION
- COMPLETED POC SUB STUDIES INCLUDING MONITORING GLUCOSE/CREATININE
- Developed site initiation visit materials for training on complex heart device implantation procedures.
- COMPLETED PI AND HEART FAILURE SPECIALIST TRAINING PRIOR TO PERSONNEL COMMENCING STUDY PROCEDURES
- MANAGED 4 CRO APPOINTED CRAS. REVIEWED REPORTS, DAYS ON SITE AND TRAINING, AS WELL AS SITE Oversight
- Managed all aspects of site management, conducted SIVs, and trained site personnel.
- RECRUITMENT OF POTENTIAL INVESTIGATORS, PREPARATION OF EC SUBMISSIONS, NOTIFICATIONS TO REGULATORY AUTHORITIES, TRANSLATION OF STUDY-RELATED DOCUMENTATION, ORGANIZATION OF MEETINGS AND OTHER TASKS AS INSTRUCTED BY SUPERVISOR AS ASSIGNED
LEAD CLINICAL RESEARCH ASSOCIATE (PERMANENT)
AMBU INC.
08.2020 - 11.2021
- Facilitated study startup by negotiating CTAs, reviewing budgets, activating sites, and managing site operations.
- MANAGED REGULATORY DOCUMENTS SUBMISSIONS TO WIRB AND LOCAL IRB
- Monitored and coordinated product shipments to ensure timely delivery.
- Developed and revised AMBU SOPs for improved compliance.
- Created site templates for ISF binder including delegation of authority log, device accountability log, training sign-in sheets, IMV, and SIV monitoring report templates to standardize documentation.
CLINICAL RESEARCH ASSOCIATE (CONSULTANT)
NAMSA INC.
05.2019 - 05.2020
- ASSISTED WITH STUDY-STARTUP INCLUDING BUT NOT LIMITED TO CTA NEGOTIATIONS, BUDGET REVIEW, SITE ACTIVATION AND SITE MANAGEMENT
- MANAGED REGULATORY DOCUMENTS SUBMISSIONS TO WIRB AND LOCAL IRB
- Monitored product shipment status to ensure timely delivery
- ASSISTED IN CREATING/UPDATING AMBU SOPS
- CREATED SITE TEMPLATES FOR ISF BINDER NOT LIMITED TO DELEGATION OF AUTHORITY LOG, DEVICE ACCOUNTABILITY LOG, TRAINING SIGN-IN SHEETS, IMV AND SIV MONITORING REPORT TEMPLATES
CLINICAL RESEARCH ASSOCIATE (CONSULTANT)
ICON PLC
05.2018 - 08.2018
- Ensured compliance with local regulations, CFR, ICH, GCP guidelines, and company and sponsor SOPs, safeguarding trial integrity and participant safety.
- Monitored clinical trials and participated in site visits, ensuring protocol compliance and effective patient identification and recruitment strategies.
CLINICAL RESEARCH ASSOCIATE (PERMANENT)
RHO
06.2017 - 04.2018
- Verified that clinical trials adhered to good clinical practices (GCP) and local and international regulations.
- Conducted comprehensive site visits before, during, and after the study to ensure compliance with protocols.
- Reviewed eligibility and ineligibility criteria against patient medical records to ensure compliance with study requirements
- Coordinated submission of serious adverse event (SAE) and adverse event (AE) reports to IRB, FDA, and study sponsor, ensuring timely communication and regulatory compliance
- Facilitated the recruitment and selection of new investigators, contract research organizations, and outside vendors.
Education
BACHELOR OF SCIENCE - TECHNOLOGY
KENT STATE UNIVERSITY
Skills
- EDC (Medidata Rave, Veeva Vault, Impact, Mednet)
- ETMF (Trial Interactive, Veeva Vault)
- CTMS (Medidata CTMS, Veeva Vault, ICO Trial)
- CAPA Identification & Resolution
- Study Start-Up & Site Activation
- Audit & Inspection Readiness
- Safety Reporting & SAE Oversight
- Protocol & ICH-GCP Compliance (E6/E8)
- Regulatory submissions
- Risk-Based Monitoring (RBM)
- Clinical trial management
- Site management
- TMF Reconciliation & QC
- Site Training & Investigator Meetings
Indications
- Hypertension
- Influenza
- Migraine
- Pacemaker
- Dry Eyes
- Chlamydia
- Bacteria Vaginosis
- Implanted Catheter
- Single-Use Scopes
- POC Dev (Glucose/Creatinine)
- Breast Cancer/Lung Cancer
- Pediatric Depression
- Hereditary Angioedema
- Glaucoma
- Osteoporosis
- Oral Contraception
- Opioids
- Stents
- Heart Valves
- Obsessive Compulsive Disorder
Therapeutic Areas
- Cardiovascular
- Infectious Disease
- Psychiatry
- Ophthalmology
- Biology
- Urology
- Gastroenterology
- Central Nervous System
- Medical Device/IVD
- Oncology
- Rheumatology
- Pain Management
- CAD
- Neurology
Timeline
SENIOR CLINICAL RESEARCH ASSOCIATE (CONSULTANT)
OXFORD GLOBAL RESOURCES
05.2022 - 02.2024
SENIOR CLINICAL RESEARCH ASSOCIATE (CONSULTANT)
CATALYST
11.2021 - Current
LEAD CLINICAL RESEARCH ASSOCIATE (PERMANENT)
AMBU INC.
08.2020 - 11.2021
CLINICAL RESEARCH ASSOCIATE (CONSULTANT)
NAMSA INC.
05.2019 - 05.2020
CLINICAL RESEARCH ASSOCIATE (CONSULTANT)
ICON PLC
05.2018 - 08.2018
CLINICAL RESEARCH ASSOCIATE (PERMANENT)
RHO
06.2017 - 04.2018
BACHELOR OF SCIENCE - TECHNOLOGY
KENT STATE UNIVERSITY