Ben Daramola
Richmond,TX
Summary
Clinical, Regulatory, and Quality Professional with 10+ years of experience in clinical trial operations, monitoring, and project support. Demonstrated expertise in site monitoring (PSV, SIV, IMV, COV), eCRF/EDC systems, regulatory compliance (ICH-GCP/FDA), and Trial Master File (TMF) management. Skilled in SAE follow-up, patient recruitment strategy, CAPA implementation, IP accountability, and vendor oversight. Adept at managing basket and master protocols, supporting clinical project planning, and ensuring data quality through proactive query resolution and risk-based monitoring. Strong communicator with cross-functional team leadership skills.
Overview
14
14
years of professional experience
Work History
Senior Clinical Research Associate II
IQVIA
03.2022 - Current
- Perform in-house clinical study data review, Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug, Assist and support the collection of key documents from sites to enable site activation timely manner
- Performed in the development of study/program plans and or SOP Development/updates as directed by the Clinical Project Manager
- Monitor recruitment, data quality, and patient safety while on site and remotely through EDC systems and direct site communication, Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (i.e., study-site webinars, newsletters, or other potential creative solutions), Liaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries
- Perform investigational product (IP) inventory, reconciliation, and review storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP
- Maintain project files including ethics committee approvals, curricula vitae of investigators and study personnel, clinical investigators brochure, protocols, case report forms instructions, consent documents, clinical-trial material shipping orders, start-up meeting attendance documentation, letters of agreement, lab reference ranges, and all investigator and site correspondence
- Conducted 1000+ site monitoring visits (IMV, COV, Risk-Based Monitoring) to ensure protocol compliance, GCP adherence, and subject safety.
- Conducted and Supported over 150 site activation (PSVs and SIVs, SWAT CRA) and ensured all regulatory, contractual, and startup documentation were complete prior to first subject enrollment.
- Performed source data verification (SDV) and resolved data queries through EDC systems such as Medidata Rave and Veeva.
- Maintained audit-ready TMF and ensured timely documentation and submission of site documents.
- Identify and complete follow-up of SAEs at study sites
- Developed and executed patient recruitment strategies, resolving recruitment barriers through webinars and site-specific campaigns.
- Supported protocol compliance and monitored for protocol deviations, implementing CAPA plans when necessary.
- Provided vendor oversight including central labs and logistics vendors.
- Contributed to project plans, SOP updates, and study-specific tools in support of Clinical Project Managers.
- Monitored basket trials under master protocols, ensuring biomarker-driven eligibility and compliance across cohorts.
- Participated in cross-functional team meetings and training site staff on GCP and protocol requirements.
Senior Clinical Research Associate
ICON
05.2017 - 03.2022
- Managed all phases of site monitoring (initiation, routine monitoring, close-out).
- Ensured compliance with ICH-GCP, study protocols, and sponsor SOPs.
- Conducted TMF QC, ISF reconciliation, and regulatory document tracking.
- Delivered ongoing site support and maintained strong communication to ensure data integrity and subject safety.
- Identified protocol deviations and coordinated CAPA implementation.
- Reviewed informed consent documentation and participant eligibility.
- Mentored junior CRAs and shared best practices for quality assurance.
Clinical Research Associate I
MDS Pharma Services
03.2014 - 05.2017
- Monitored SAEs and managed eTMF documentation.
- Authored monitoring visit reports and followed up on outstanding queries.
- Supported clinical trial execution with regulatory binder reconciliation and protocol compliance tracking.
- Liaised with clinical project leader to effectively resolve study-related issues.
- Conducted meetings with sponsor representatives to discuss clinical study developments.
Clinical Research Coordinator
MD Anderson Cancer Center (MDACC)
02.2012 - 03.2014
- Scheduled patient visits and maintained participant logs and regulatory files.
- Ensured data accuracy through timely CRF entry and source document review.
- Assisted with informed consent and protocol compliance.
Education
B.Sc. - Civil Engineering
Federal Polytechnic
Ado EkitiA.A.S. - Petroleum Field Service Technician
Lone Star College
Houston, TXCertificate - Project Management Professional (PMP)
Project Management Institute
Certificate - Basic Life Support
Post Graduate Institute of Medicine
Denver, CO11-2025
Skills
- Site management, Site Monitoring Visits (PSV, SIV, IMV, COV), Site Activation & Study Start-Up Support, Risk-Based Monitoring (RBM), Informed consent process, Informed Consent Process & Documentation, Protocol Deviations & Data Quality Monitoring
- Ability to track and provide study specific information and updates to internal and external teams utilizing databases, spreadsheet and other tools
- Clinical Project Management Support, Vendor / CRO, Clinical trial management Oversight, Basket Protocol Design
- Analytical skills, Analytical thinking, Inspection Readiness
- Laboratory results management, Case report management
- Team leadership qualities, Data Integrity & Quality Management
- SAE Identification & Follow-up, Data Query Resolution & CRF Review, Patient Recruitment & Retention Strategies, Investigational Product (IP) Accountability
- EDC Systems (Medidata Rave, Veeva, IBM Clinical, Medrio, Wingspan), Trial Master File (TMF) / ISF Oversight
- Regulatory Compliance (ICH-GCP, FDA, EU IVDR), CAPA Implementation
- Reviewing data standards, Patient recruitment strategies
- Clinical Process Overview with EU IVDR Focus
- Effective communication, Time management abilities
Therapeutic Area Experience
- Oncology: Solid Tumor, Lymphoma, Myeloma, T-Cell Therapy, Colorectal, Breast Cancer
- Rare Diseases: Fabry, Gaucher, Spinal Muscular Atrophy (SMA), Sickle Cell, Soft tissue sarcoma, Fragile X syndrome, Hemophilia A/B
- IVD / Medical Devices: PACs, Cardiac Pacemakers, Heart Valves, TBI
- Dermatology: Psoriasis, Acne, Eczema, Alopecia, Vitiligo
- CNS: Cerebral Palsy, MS, Parkinson’s, Huntington’s disease, Migraine, Acute Pain
- Cardiovascular: AFib, Hypertension, Stroke, Heart Failure
- Neurology: Neurodegenerative Disorders (Alzheimer’s, Parkinson’s, ALS), Epilepsy & Seizure Disorders, Multiple Sclerosis & Demyelinating Disorders, Pain & Headache, Cerebrovascular Disorders
- Respiratory: Chronic Lung Diseases (COPD, Asthma, Pulmonary Fibrosis), Pulmonary Hypertension, Allergic & Inflammatory Airway Diseases
- Infectious Diseases: COVID-19 Vaccine, HPV, AIDS
- Ophthalmology: Diabetic Retinopathy, Glaucoma, Ocular Infection
- Diagnostics: Molecular Diagnostics, PCR, Immunoassays, Toxicology
Timeline
Senior Clinical Research Associate II
IQVIA
03.2022 - Current
Senior Clinical Research Associate
ICON
05.2017 - 03.2022
Clinical Research Associate I
MDS Pharma Services
03.2014 - 05.2017
Clinical Research Coordinator
MD Anderson Cancer Center (MDACC)
02.2012 - 03.2014
A.A.S. - Petroleum Field Service Technician
Lone Star College
B.Sc. - Civil Engineering
Federal Polytechnic
Certificate - Project Management Professional (PMP)
Project Management Institute
Certificate - Basic Life Support
Post Graduate Institute of Medicine