Who is Frank O U? Overview
A concise factual answer block for searchers comparing this professional profile.
Quick answer
Frank O U is listed as Senior Clinical Research Associate III at IQVIA, based in United States. AeroLeads shows a matched LinkedIn profile for Frank O U.
Frank O U previously worked as Senior Clinical Research Associate II at Iqvia and Senior Clinical Research Associate at Rho. Frank O U holds Master Of Business Administration - Mba, Business Administration And Project Management from American Intercontinental University.
Company email context
Email format at IQVIA
This section adds company-level context without repeating Frank O U's masked contact details.
IQVIA
Review company-level records connected to Frank O U before choosing the right outreach path.
Profile bio
About Frank O U
I am an experienced Senior Clinical Research Associate with drug and medical device experience managing site and being a resource ensuring alignment to protocol, SOP, regulatory compliance and monitoring plan. I act as the primary site contact throughout all phases of a clinical research study, taking overall responsibility of allocated site's data verification and accurate reporting.TECHNICAL PROFICIENCYClinical Trial Management System (CTMS), Electronic Trial Master File (eTMF), Electronic Data Capture (EDC), electronic informed consent solutions (eICF), Electronic Clinical Outcome Assessment (eCOA), electronic patient-reported outcome (ePRO) Data Management, MS OfficeCORE COMPETENCIESSite management, Risk-Based Monitoring, Remote Monitoring, Budget Tracking, Project Management, FDA Audit Preparation/ResponsesTHERAPEUTIC AREAS Oncology– Prostate Cancer, Small Cell Lung cancer, Solid Tumor - Breast CancerMedical Device– (Premarket Approval, Postmarket Surveillance, Class I, II, III, IV, Investigator Led Study, Investigational Device Exemption (IDE)), Medical Device Reporting (MDR) MDR (EU) 2017/745 regulation (21 CFR Part 803), QMS, Quality System Regulations (QSR21 CFR820),Canadian Medical Device Regulation (CMDR),EU Medical device Directive (EUMDD 93/42 EEC), and ISO 13485:2003 and 14155:2011.IVD (In Vitro Diagnostics)- Laboratory-developed Tests (LDTs), POCs (Point of Care Tests), Various Assay Panels and Biomarkers for Cardiology and Oncology, PCRCNS- Parkinson, Pain, Multiple Sclerosis, AlzheimerMetabolic Disease-Type 1 & Type 2 DiabetesInfectious Disease- COVID-19 (Vaccine), HPV, AIDSRare Disease- Cystic FibrosisOphthalmology- Glaucoma, Retina, Dry Eye DiseaseDermatology - Male and Female Androgenic Alopecia, Atopic Dermatitis, Acne, Nonmelanoma Skin Cancer
Current workplace
Frank O U's current company
Company context helps verify the profile and gives searchers a useful next step.
6 roles
Frank O U work experience
A career timeline built from the work history available for this profile.
Senior Clinical Research Associate Ii
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.
Jul 2022 - Present
Senior Clinical Research Associate
. Provided oversight/execution of feasibility, selection set up, conduct and closure of clinical trials within the allocated regions, per ICH-GCP, applicable legislation and Company Standard Operating Procedures.• Served as the primary contact for day-to-day site management.• Developed clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal supervision.• Ensured applicable trial registration from study initiation through posting of results and support publications as needed.• Provided management/oversight of ordering, tracking, and accountability of investigational products and trial materials.• Interfaced and collaborated with site personnel, IRBs/ECs, contractors/vendors, andcompany personnel.• Oversaw the development and execution of Investigator agreements and trial payments.• Responsible for clinical data review to prepare data for statistical analyses andpublications.• Performed monitoring activities including site qualification visits, site initiation visits,interim monitoring visits or close out visits based on study need.• Contribute to the development and delivery of appropriate strategy sessions for globalprojects.. Responsible for delivery of assigned clinical projects, through effective partnership withthe study core team leading to delivery of clinical project commitments (deliver on time,within budget and in compliance with regulations and SOPs);• Tracked and managed assigned project budgets to ensure adherence to business plans.• Support clinical scientific discussions with regulatory agencies/ notified bodies to drivesupport of the clinical and regulatory strategy.• Developed a strong understanding of the pipeline, product portfolio and businessneeds.• Serve as the clinical representative on Product Development team.
May 2020 - Jul 2022
Clinical Research Associate Ii
Responsible for supervising, monitoring, and supporting the administration and progress of clinical trials. Monitors and conducts oversights of all visit types while ensuring adherence to GCP, ICH, SOPs and applicable compliance with all study procedures while serving as a liaison to clinical study management, field clinical personnel and site personnel by responding to any protocol related issues and escalating as appropriate.
Feb 2017 - Apr 2020
Clinical Research Associate I
Monitoring the progress of clinical studies at investigative sites, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements while governing minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance and objectives and cooperation with other project team members.Governed
Oct 2014 - Feb 2017
Clinical Research Coordinator
• Responsible for all aspects of conducting clinical trials to ensure strict protocol and Food and Drug Administration (FDA) guidelines are met as well as study budgets and timelines.• Communicated with study sponsors, primary investigators as required by the needs of the study and work closely with the comprehensive team.• Coordinated trial participants covering informed consent, screening, and inclusion of the subjects adhering to safety and compliance issues.• Assessed patients for inclusion, exclusion criteria, and appropriateness of study participation.• Maintained complete records for each study in an organized manner that meets regulatory criteria.• Source document creation and management.• Dose study participants with study drug(s) per protocol and randomization.• Ensured participant safety was a priority through observation and collection of adverse events.• Coordinated and submitted all necessary forms, protocols, and consents to IRB.• Performed venipuncture, preparation of specimens, handling, packaging, shipping of hazardous materials to the appropriate sites.
Jan 2012 - Oct 2014
2 education records
Frank O U education
Master Of Business Administration - Mba, Business Administration And Project Management
American Intercontinental University
Bachelor'S Degree, Microbiology, General
University Of Jos
FAQ
Frequently asked questions about Frank O U
Quick answers generated from the profile data available on this page.
What company does Frank O U work for?
Frank O U works for IQVIA.
What is Frank O U's role at IQVIA?
Frank O U is listed as Senior Clinical Research Associate III at IQVIA.
Where is Frank O U based?
Frank O U is based in United States while working with IQVIA.
What companies has Frank O U worked for?
Frank O U has worked for Iqvia, Rho, Parexel, and Md Anderson Cancer Center.
How can I contact Frank O U?
You can use AeroLeads to view verified contact signals for Frank O U at IQVIA, including work email, phone, and LinkedIn data when available.
What schools did Frank O U attend?
Frank O U holds Master Of Business Administration - Mba, Business Administration And Project Management from American Intercontinental University.
Find 750M verified contacts
Search by job title, company, industry, location, and seniority. Export verified B2B contact data when you need it.
Start free trial