Clinical Research Professional Experience

UCHEGBULAM, ANTHONY

**** ******** ***. ***. ** Bristol, PA 19007 267-***-**** *****************@*****.***

Professional Summary

* ***** ** * ******** Research Monitor

THERAPEUTIC EXPERIENCE

Endocrinology

Cardiology

Database and Technical Skills

Electronic Data Capture: INFORM® V. 4.6, MediData RAVE®

CTMS®, Oracle

IVRS Ramos®, ClinPhone®.

MS Outlook, MS Excel, and MS Word.

PROFESSIONAL EXPERIENCE

Integrated Resource Inc. Dec 2013-Date

Home-Based Regional Clinical Research Associate

Responsibilities include monitoring all phases of clinical trials; assure adherence to Good Clinical Practices.

Schedule/conduct pre-study visits, site initiation visits, routine monitoring visits and close out visits.

Ensure clinical sites’ compliance with protocols, regulations and guidelines.

Reconcile site regulatory binder assuring collection and completeness of regulatory documents.

Assure timely completion and submission of CRFs according to Clinical Monitoring Plan (CMP).

Assure timely and accurate completion of Data Clarification Forms (DCFs).

Collect/ensure completeness of all essential regulatory documentation.

Verify Informed Consent Forms and ensure completion before each subject’s participation in a trial.

Verify source document against Case Report Form/Electronic Data Capture.

Ensure all adverse events are reported and tracked per regulatory requirements.

Deliver quality written trip reports, confirmation and follow-up letters within timelines of

SOPs.

Perform drug accountability procedure including storage, inventory and return/destruction.

Issue and ensure timely resolution of all data queries.

Attend clinical monitoring staff meetings, project team meetings and clinical training sessions according to the project communication, and monitoring plans and making presentations when required.

Maintain timely and effective communication among team members and site staff.

Perform other duties as assigned by Lead Clinical Research Associate.

EDUCATION

BACHELOR’s DEGREE 1998--2002 INSTITUTE of MANAGEMENT and TECHNOLOGY, ENUGU NIGERIA (WES ref. #:2966750)

Major: Banking and Finance

Related coursework:

The Impact of Effective Risk Management on the Profitability of Nigerian Banks

REFERENCES

Available upon request

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