Summary
Overview
Work History
Education
Skills
Therapeutic Areas
Timeline
Generic

Ola Benjamin

Houston,TX

Summary

Clinical, Regulatory, and Quality Professional with significant experience across clinical operations, and regulatory activities as well as expertise in quality assurance activities. Successful track record in clinical project management, data management, and successful FDA regulatory submissions. Extensive background in collaborating with and managing vendors (CROs, Safety Monitoring, EDC, CTMS systems, TMF management, Data Management). Responsible for leading and supporting one or several clinical trials while fostering strong, productive relationships with colleagues across various clinical trials. Possesses strong communication, Coaching, Delegation, and Relationship building skills used in team problem-solving. Additionally, experience in new product development and strategic planning for product delivery to market as an FSP CRA

Overview

12
12
years of professional experience

Work History

Senior Clinical Research Associate II

IQVIA
03.2022 - Current
  • Implements and monitors clinical trials to ensure sponsor and investigator obligations are met and compliant with applicable local regulatory requirements and ICH guidelines
  • Performs investigative site file reconciliation, requests any new or updated site-related essential and non-essential documents, and reviews them for content, consistency with other documents and compliance with appropriate local regulatory requirements, ICH GCP guidelines, project SOPs and sponsor requirements
  • Performs source document verification, independently performs case report forms (CRF) and performs query resolution in a timely manner while overseeing device accountability and safety at investigative sites according to IVD guidelines
  • Ensures Serious Adverse Event (SAE) reporting according to project specifications, reviews SAE information, resolves queries and assists sites in completion of SAE reports
  • Generates reports for site and project management using CTMS and Works under supervision to manage workflow to accomplish assigned objectives.
  • Provided expert guidance to CRAs, fostering a culture of continuous learning and professional growth.
  • Collaborated with biostatistics team members on data analysis plans, ensuring accurate interpretation and reporting of study results.
  • Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
  • Designed effective training materials for site personnel, enhancing understanding of study procedures and expectations.
  • Strengthened collaboration with cross-functional teams, ensuring clear communication and alignment on project goals.
  • Facilitated seamless transitions between study phases through proactive planning, coordination, and communication with internal stakeholders.

Senior Clinical Research Associate

ICON
05.2017 - 03.2022
  • Performed clinical study site management, monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents
  • TMF QC and maintenance
  • Performed remote and on-site monitoring & oversight activities using various tools to ensure Data generated at site is complete, accurate and unbiased and Subjects' right, safety and well-being is protected
  • Conducted site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner
  • Collected, reviewed, and monitored the required regulatory documentation for study start-up, study maintenance and study close-out
  • Communicated with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits and inspections and overall site performance
  • Identified, assessed and resolved site performance, quality or compliance problems
  • Managed and maintained information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines
  • Contributed strongly to CRA team knowledge, shared best practices, made recommendations for continuous improvement and provided training as required.
  • Strengthened collaboration with cross-functional teams, ensuring clear communication and alignment on project goals.
  • Facilitated seamless transitions between study phases through proactive planning, coordination, and communication with internal stakeholders.
  • Mitigated risks to subject safety or study integrity by promptly identifying issues during site visits and implementing corrective actions as necessary.
  • Advanced the organization''s clinical research capabilities by staying abreast of industry trends, attending relevant conferences, and sharing learnings with colleagues.
  • Designed effective training materials for site personnel, enhancing understanding of study procedures and expectations.

Clinical Research Associate I

MDS PHARMA
03.2014 - 02.2017
  • Ensured safety at investigative sites by verifying proper recording and reporting of Serious Adverse Events (SAEs)
  • Performed investigative site file reconciliation of the regulatory binder, eTMF, and query resolution; requested any new or updated site-related essential and non-essential documents and reviewed them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements
  • Completed monitoring trip reports confirmation and follow-up letters for all monitoring visits, within the appropriate and designated timeframes for each visit
  • Participated in the development, review, and implementation of project study procedures and regulatory binders
  • Responsible for coordinating input from Clinical Study Team to resolve site-specific issues.
  • Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process.
  • Streamlined clinical trial processes for increased efficiency, utilizing strong organizational skills.
  • Collaborated with cross-functional teams to successfully meet project timelines and deliverables.

Clinical Research Coordinator

MD ANDERSON CANCER CENTER MDACC
03.2012 - 10.2014
  • Performed and assisted in data entry, management, and data analysis using EDC systems
  • Addressed and resolved queries in a timely manner
  • Scheduled and called subjects for appointments; contacted participants with reminders or other requirements
  • Performed administrative duties in the preparation of regulatory documents
  • Maintained all forms and documents, including consent forms and master subject logs
  • Filed all appropriate correspondence.
  • Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
  • Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.

Education

Bachelor of Science - Civil Engineering

THE FEDERAL POLYTECHNIC
ADO EKITI, NG
02.2011

Skills

  • Good Clinical Practice and ICH (GCP)
  • Clinical Process Overview with EU IVDR Focus
  • Data Integrity Overview
  • Good knowledge of drug development process, clinical trial monitoring procedures, medical terminology and GCP/ICH guidelines
  • Ability to track and provide study-specific information and updates to internal and external teams utilizing databases, spreadsheet and other tools
  • In-depth knowledge of ICH-GCP, EU and FDA requirements
  • Ability to conducts periodic site file audits to ensure compliance with GCPs
  • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
  • Experienced in monitoring and/or coordinating clinical trials with >75 PSVs, >110 SIVs, >450 IMVs, and >50 COVs
  • Solid knowledge in the use of most EDC systems (Medidata Rave, IBM Clinical, Medrio, Wingspan, iMednet, Veeva etc)
  • Solid knowledge in the use of most CTMS systems (Medidata, Veeva, eClinical etc)

Therapeutic Areas

  • ONCOLOGY: Solid Tumor, Lymphoma, Myeloma, Colorectal Cancer, T-Cell Therapy, Breast Cancer
  • IVD/ MEDICAL DEVICE: Pulmonary Artery Catheters, Cardiac Pacemakers, Heart Valves, IVD, TBI
  • DERMATOLOGY: Psoriasis, Eczema, Acne, Alopecia, Vitiligo.
  • CNS: Cerebral Palsy, Multiple Sclerosis, Parkinson's disease, Migraine, Acute Pain.
  • CARDIOVASCULAR: Heart Failure, Atrial Fibrillation, Hypertension, Pulmonary Fibrosis, Stroke.
  • OPHTHALMOLOGY: Diabetic Retinopathy, Glaucoma, Ocular Infection.
  • INFECTIOUS DISEASES: Covid-19(Vaccine), HPV, AIDS
  • IVD: Point of Care, Molecular Diagnostic, PCR, Immunoassays, Toxicology, Cancer multi-panel detection.

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
03.2014 - 02.2017

Clinical Research Coordinator

MD ANDERSON CANCER CENTER MDACC
03.2012 - 10.2014

Bachelor of Science - Civil Engineering

THE FEDERAL POLYTECHNIC

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