DAMILARE GEORGE

702-***-****/ adv5pn@r.postjobfree.com

http://linkedin.com/in/damilare-george-b57b51105

Las Vegas, NV

PROFESSIONAL SUMMARY

Passionate clinical research professional: attentive to details, highly organized and constantly looking for ways to improve. Very well versed in all aspects of clinical research trials, both at large multilayered institutions and small private practices. Possess practical knowledge of GCP-ICH guidelines and FDA regulations. Adept at strategic planning and very analytical. Proven track of successfully meeting schedules and deadlines, and great interpersonal skills. Competent in windows applications (Excel, Word, Power Point, etc.), and customer service. Accustomed to working in fast-paced environments as well as independent. Great at multitasking, innovation, and organizational skills.

Authorized to work in the United States for any employer.

EDUCATION

Doctor of Medicine (MD) 2014 – 2018

Jonelta Foundation School of Medicine, University of Perpetual Help System Manila, Philippines 1740

Certificate in Global Health 2016 - 2017

United State University, San Diego, USA

Bachelor of Science in Microbiology 2010 – 2014

Federal University of Agriculture Abeokuta, Ogun State, Nigeria

SOFTWARE COMPETENCIES:

Ms. Words, Excel, PowerPoint, etc. eTMF systems (Veeva Vault), Inform, Siebel, Firecrest, Investigator Space, Velos, CTMs, Medrio, SharePoint, Florence, IntraLinks, 4G, Almac, and Medidata Rave.

IRB: Cirbi, Connexus, Alpha IRB, Advarra.

PROFESSIONAL EXPERIENCE

Clinical Research Associate, Iavi (Remote based out of Africa) Oct 2020 - Dec 2022

●Performed all monitoring activities such as site qualification visit, initiation visit, interim monitoring and close out visit as required.

●Train the site personnel on study protocol, vendor management, regulatory submission, study procedures, and training on eCRF completion.

●Obtains, reviews, processes, and tracks study related documents (CVs, FDA 1572s, GCPs/IATAs, lab certifications, IR approvals, contracts, protocols, etc.)

●Performs investigational product accountability, review storage conditions of clinical trial materials as required by sponsor and ensures return of unused materials to designated location or verifies destruction per SOP.

●Verified required clinical data entered in the case report form (CRF) is accurate with medical records and complete source data review and verification.

●Performed query resolution until closure, opened action items and provided guidance to site staff as necessary.

●Performed review of Informed Consents (ICF), subject documentation and other regulated documents for Institutional Review Board (IRB) approval.

●Reviews the quality and integrity of the clinical data through review of electronic CRF data and on-site source verification Participated on project teams, task forces and other teams to develop and centralize Clinical Monitoring.

Medical Officer/Sub-I, Lagos State University Teaching Hospital (Nigeria) Apr 2018 – Aug 2020

●Collected records and maintained accurate pt information in compliance with regulations.

●Document tasks such as past medical history, demographic information and provide advice on open clinical trials to subjects.

●Secondary review of subject eligibility and informed consent process.

●Provided protocol training, lab manual and applicable study related trainings to new hires.

●Reviewed SAE and Con-Meds reconciliation.

●Reviewed lab, vital signs and oversee study procedures such as con meds, performance score, etc

●Attended Investigator Meetings and/or sponsor face to face meetings.

●Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

●Provided insights on pt recruitments and retention.

●Performed final IP accountability of blinded studies during close out.

●Administered treatment and consulted with appropriate specialists when necessary.

Clinical Trial Associate/ CRC, Center for Clinical Care and Research (Nigeria) April 2013- Dec 2014

●Monitored several sponsored partner studies (AbbVie, CDC, NIH, Clinton Health Initiatives, etc) for certain PIs in the local department separately and CROs.

●Performed regulatory submission and interacted with several CTMs, PMs, SMs to provide updates and metrics.

●Obtain informed consent and screen patients for eligibility for current studies.

●Performed study and site-lite site activation and overall site management such as updating 1572, CVs, ML, training logs, vendor access and DOA log.

●Send study drug order form to pharmacy and facilitate drug administration.

●Improved patient experience by ensuring successful completion of treatments (radiotherapy, chemotherapy) at labs for cancer research participants.

●Maintained Trial Master Files (eTMF), study trackers, and ensure site regulatory documents are up to date.

●Assisted with queries resolution, action items follow up and escalate issues to the study team as applicable

●Assisted assigned CRA with remote SDR/SDV and ISF reconciliation by getting source ready

●Handled shipping of study supplies (IB, binders, pharmacy labs, protocols, etc) and all other sample specimens.

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