Clinical research associate work from home/travel

VIVIEN EDI, MD.

**** ***** **** **,*** ****D Marietta GA 30067

Tel: 424-***-**** E-mail: *********@*****.***

CAREER OBJECTIVE

A Clinical Research position that utilizes my training and experience in clinical research to coordinate, monitor and manage all aspects of clinical studies in accordance with the ICH Good clinical practices, FDA guidelines, local regulations and the standard operating procedures to work as part of a team. SUMMARY OF QUALIFICATIONS:

knowledgeable CRA

Knowledgeable in current GCP/ICH guidelines applicable to clinical research. Multi-therapeutic clinical knowledge

Strong knowledge of clinical research process and medical terminology Use of electronic data capture system (EDC)

Conversant with the Review of Case Report Form (CRF) Essential document collection and Site Binder review Identification of potential study sites

Coordinate investigator meeting/start-up dates with field monitors Site Monitoring visits (including PSVs, SIVs, IMVs and COVs) to meet study expectations Source data/document verification (SDV)

Participate in development of informed consent forms Reporting of adverse events according to regulations and company policy Ability to prepare and maintain records, and to train others Possesses excellent organizational and interpersonal skills Strong organizational, multitasking, analytical and problem solving skills Ready and willing to accommodate regional and domestic business travels THERAPEUTIC AREAS:

Oncology: Prostate, Lung, Ependymoma, Colon, Solid tumors Cardiovascular: Congestive Heart Failure, Essential Hypertension, Neurology: Pain, Sciatica, Migraine, Amyotrophic Lateral Sclerosis Infectious Disease: HIV, PID

Women's Health: Contraceptives (Tubal Ligation)

Respiratory: COPD, Asthma, Bronchitis, Cystic Fibrosis PROFESSIONAL WORK EXPERIENCE:

Education Commission for Foreign Medical Graduate(ECFMG) Certified Shadow Doctor /medical Assitant 2016 - present

Wellstar Urology Clinic

Wellstar Health system Inc.

The Clinical Research Centre Inc. INTERN 2011

Clinical Research coordinator

Assist in the identification of potential study sites. Identify/select investigators who will be responsible for the conduct of the trial. Set up the trial sites, which includes ensuring each center has the trial materials, including the investigational medicinal product.

Review CRF’s, data management plans, study reports, and informed consents. Conduct source data/document verification (SDV).

Monitor trials throughout their duration by conducting various Site Monitoring visits (including PSVs, SIVs, IMVs and COVs) to meet study expectations for different types of trials. Perform training of the site staff to trial-specific industry standards. Perform drug accountability ensuring that sites receive and maintain study drug according to the protocol. Monitor trials throughout their duration by conducting various Site Monitoring visits (including PSVs, SIVs, IMVs and COVs) to meet study expectations for different types of trials. Write visit reports and close out trial sites on completion of the trial. Liaise with doctors/consultants or investigators on conducting the trial. Training the site staff to trial-specific industry standards. Verify that data entered on the CRFs is consistent with patient clinical notes. Collect completed CRFs from hospitals and general practices. Family Care Association (Non-Governmental Organization) Jan 2012 Medical Officer

Program Officer - National Malaria Control.Nigeria,West Africa Quality Control Officer - Environmental Health and Intervention, Nigeria, West Africa Monitor trials throughout their duration by conducting various Site Monitoring visits (including PSVs, SIVs, IMVs and COVs) to meet study expectations for different types of trials. Write visit reports and close out trial sites on completion of the trial. Training the site staff to trial-specific industry standards. Collect completed CRFs from hospitals and general practices. Medical Officer - Occupational Health and Related Hazards, Infectious Disease and Control, Nigeria, West Africa

Procurement Officer - Medical Equipment and Facilities, Nigeria, West Africa Schedule Officer - Project Monitoring and Evaluation, Nigeria, West Africa Primex Hospital Lagos,Nigeria 2012 – 2014 Medical Officer Clinical Research Coordinator

National Youth Service

Labor Ward officer/ Obstetrics Emergencies.

Medical Officer in-charge of infertility and reproductive health Doctor on-call Gynecological emergencies

Doctor on-call Obstetrics Sonography.

Assistant Surgeon, Obstetrics, Gynecology and other related Surgeries EDUCATION AND CLINICAL TRAINING:

Education Commission for Foreign Medical Graduate (ECFMG) Certified EVALUATED COLLEGE DEGREE (ECFMG) Bachelor of Science. Bachelor of Medicine. Igbinedion University, Edo State, Nigeria

Bachelor of Medicine, Bachelor, of Science (M.B.B.S) – 2010 Computer Skills:

Microsoft Word, Microsoft Excel, PowerPoint, Internet Skills Languages:

English Language: Fluent, written and conversational

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