Research Associate Clinical

OLUWOLE ATOE ASOKEJI

PHONE: 919-***-****

EMAIL: **********@*****.***

ADDRESS: New Jersey, USA

SUMMARY

A flexible and knowledgeable Clinical Research Associate with over 6 plus years of clinical research experience. Excellent knowledge in phases I-II clinical trials and study start up.

SKILLS

oExperience in phases I-II clinical trials.

oArticulate, with strong communication skills.

o7+ years of clinical research experience.

oAbility to travel as needed.

oAbility to use logic and reasoning to identify the strengths and weakness of alternative solutions, conclusions, and approaches to problems.

oProficient with Microsoft packages such as word, excel, PowerPoint and the use of Veeva vault for the TMF input.

oProactive, versatile, and confident with the ability to work well under pressure and tight deadlines.

oExcellent organization skills and demonstrated analytical skills.

THERAPEUTIC AREA OF EXPERTISE

oNeurology: Schizophrenia, Multiple Sclerosis, Parkinson Disease and Alzheimer’s Disease

oRare Disease: Muscular Dystrophy

oOncology: Non-Small Cell Lung Cancer, Multiple Myeloma, CAR-T Cell and Acute Myeloid Leukemia

oMedical Device: In Vitro Diagnostics/ Large Joint Knee Implant

SUMMARY OF EXPERIENCE

Exactech Inc, Gainesville, Fl

Clinical Research Associate II Dec 2022- Current

oPerforms site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and protocol compliance in relation to Large Joint Knee Implant procedures.

oPrepares email to request a site visit and the confirmation letter for the monitoring process. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.

oRoutinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).

oConducts Source Document Review of appropriate site source documents and medical records

o Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation.

oPulls reports from the EDC {i.e Products, AE’S, Query and Visit schedule} to ascertain the data verification purposes of the site compliance requirements.

oReviews the data and site folders to access what documents may be needed to make the eTMF current

oEnsures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.

Parexel International; New Jersey Clinical Research Associate I Jan 2020 – Dec 2022

oPerforms site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance in relation to the Oncology study phases I, II & III

oUses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the Oncology project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.

oVerifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient.

oAssesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

oConducts Source Document Review of appropriate site source documents and medical records.

oVerifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records.

oApplies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.

oUtilizes available hardware and software to support the effective conduct of the clinical study data review and capture on Oncology studies

oPerforms investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.

oVerifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.

oSupports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.

Parexel International; MA

Clinical Trial Associate Jan 2017 – Jan 2020

oSupported the Clinical Operations teams in study execution.

oCollaborated with Clinical Trial Managers, Clinical Research Associates, and Contract Research Organizations to support ongoing trial monitoring activities.

oEnsured Inspection Readiness by managing the set-up, maintenance, and quality control of the internal Trial Master Files and overseeing the CRO’s management of Trial Master Files.

oManaged the Clinical Operational internal document filing system and documents.

oContributed to the preparation of trial-related materials (clinical protocols, Informed Consent Forms, Case Report Forms, Standard Operating Procedures, Monitoring Plans, Laboratory Manuals, Pharmacy Manuals, Study Reference Manuals).

oAssisted in the coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages and IP release.

oAssisted with planning, preparation, and on-site or remote support of investigators meetings.

Rutgers University; New Jersey

Clinical Research Coordinator Feb 2015 – Jan 2017

oDesigned and maintained source documentation/work flows based on study protocol requirements.

oOrganized study patient visits.

oPerformed study procedures and collected data from patients participating in a clinical trial.

oPerformed ECGs, breathing tests, vital signs, etc.

oReviewed and processed medical records.

oProcessed and packaged labs.

oCorresponded with patients.

oScheduled and mentored patients.

oSubmitted and managed study data for pharmaceutical sponsors.

EDUCATION

oUniversity of Lagos, Nigeria (Bachelors Accountancy) 1999 – 2004

oYaba College Of Technology (Associates Accountancy) 1996 – 1998

CERTIFICATION

NIDA CLINICAL TRAILS NETWORK {ICHGCP Version 5} 2022

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