ONYINYECHI OBIOHA

**** ******* ***** **********, **, 20774

301-***-****

ac83of@r.postjobfree.com

CLINICAL RESEARCH SPECIALIST

Highly skilled clinical research associate with a continuous track record of success in clinical environments. Experienced in monitoring multiple site locations, clinical site evaluations, initiation, maintenance, and close-out visits in accordance with Good Clinical Practice (GCP) and company SOPs while maintaining confidential data and following timelines.

PROFESSIONAL SKILL SUMMARY

Knowledge of Company policies and procedures

2 years of experience in clinical research

2 + years of clinical monitoring experience in phases I, II and III clinical trials

Excellent written and oral communication

Excellent technical writing

Excellent knowledge of ICH/GCP

Ability to manage investigative sites

Ability to escalate issues appropriately

Identifies scientific misconduct at the site level

Describes and demonstrates the principals of IP accountability

Ensures timely submission of trip reports according to company timeline

Advanced knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS and Electronic Data Capture platform

CLINICAL RESEARCH TRAINING

GCPs/ICH Guidelines

CAPA

Fraud and Misconducts

NIH Protecting Human Research Subjects

FDA Guidelines (21CFR Parts 50,54,56,312)

HIPAA Regulations

Monitoring Guidelines and Procedures

Regulatory Documents – Review and Processing

SAE And PDs – Review, Reporting and Handling

CRF Review

IATA

THERAPEUTIC EXPERIENCE

• Infectious disease: Hepatitis C

• Oncology: Breast and Lung Cancer

• Endocrinology: Diabetes

• CNS: Bipolar Disorder, Major Depression

• Cardiology: Hypertension, Stroke, Atrial Fibrillation

• Respiratory: Asthma.

PROFESSIONAL EXPERIENCE

Clinical Research Associate, Provance Clinical Inc., CA 07/2016-Present

• Coordinates and provides oversight for specific activities to ensure client and sponsor expectations are met in compliance with any phase study design

• Performs submissions and notifications to Regulatory Authorities, IECs and other bodies according to applicable guidelines, regulatory requirements and SOPs.

• Identifies potential unreported Adverse Events and Serious Adverse Events during patient interview and appropriately processes according to study protocol guidelines and sponsor SOPs.

• Coordinates and conducts PSSV, SIV, and COV visits to assess the qualification of potential study sites, to initiate and instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected, and to terminate studies

• Provides support in maintaining clinical project documents, including Site and/or Data Management Plans, Monitoring Guidelines, Data Review Guidelines, Site Operations Manuals, and Monitoring Visit Letter Templates under guidance of Operational Team Lead

• Acts as primary point of contact for assigned study sites

• Tracks patient enrollment, study supplies, and data entry efforts for assigned study sites.

• Monitors drug inventory, dispensing, compliance and return and ensures that used and expired medication are returned to the sponsor or disposed per pharmacy guidelines.

• Training and re-training of new research personnel, including Study Coordinators, Investigators, and site pharmacists.

• Conducts site equipment’s inspection and site SOP to ensure patient safety and adherence to protocol

Clinical Research Coordinator; Provance Clinical Inc., CA 01/2014-06/2016

• Communicated with sponsors, investigators, clinical monitors and colleagues to ensure effective clinical trial implementation and progress

• Initiated and maintained required clinical and regulatory files

• Coordinated and participated in program activities, grant applications, oral/poster presentation, conferences, departmental meetings, continuing education, investigator meetings, site initiation, interim monitoring and closeout study visits as assigned

• Administered and/or dispensed investigation agents as needed

• Monitored patients' study progress to fulfill protocol and sponsor requirements

• Completed clinical course of study subjects as required per protocol, including, but not limited to, laboratory tests vital sign measurement, EKGs, health status assessment and adverse event monitoring

• Worked closely with Director and Primary Investigator developing/implementing budgets, work schedules and performance requirements for any additional personnel

• Supervised research assistants, residents, medical students, undergrad students in all lab related activities

EDUCATION:

University of Maryland, University College

Master’s in HR Management

2018-Present

CRA ACADEMY

San Bernardino, CA

Accreditation Council for Clinical Research Education (ACCRE)

IVRS : Clinphone

Imo State University, Nigeria

Bachelor of Science Accounting

2002-2006

SKILLS & INTERESTS:

COMPUTER:

Microsoft Office (Excel, SharePoint, Outlook, Visio), Adobe Acrobat.

TRAVEL:

France, South Africa, Indonesia, Spain, Italy, Singapore, Egypt

INTERESTS:

Community Volunteering, Cooking, Reading

HIGHLIGHTS:

Leadership skills

Interpersonal Skills

Communications Skills

Team Player

Problem Solving

Attention to Detail

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