Clinical Research Management

NEKA LEGBARA

**** ******** *****

Lewisville, TX 75067

Email: ****.***@*****.***

Phone: 214-***-****

OBJECTEIVE:

An experienced, self-motivated, and detail oriented Clinical Research Associate with a strong sense of duty and responsibility, excellent interpersonal skills, ability to multi-task and coordinate several projects in a timely manner, seeking a growth position in a leading Clinical Research Organization.

EXPERIENCE:

CRA I

INVENTIV HEALTH CLINICAL. March 2013 – July 2015

Performed study site management including pre-study, initiation, routine monitoring and close-out of clinical trials and maintenance of study files.

Prepared accurate and timely trial reports.

Ensured patient safety by adhering to GCP, SOP, Protocol and research standards.

Reported and wrote reports on AEs and SAEs based on patient safety.

Assisted with recruiting investigators, collecting investigator documents, site management and preparation of monthly status reports.

Attended project team/ Investigator meetings.

Acted as the liaison between Sponsor and Investigator.

Verified the accuracy of CRF entries, source documents and other trial related records.

Reported site safety issues, AEs, SAEs and other protocol information to sponsor.

Verified written informed consent forms are signed and obtained from trial subjects before their participation in trials.

Ensured that site staff and Investigator are well informed and trained about the trial and protocol.

Managed and monitored all aspects of clinical studies in accordance with FDA regulations, SOPs and ICH and GCP guidelines for clinical research.

Took charge of all regulatory document collections, clinical supply shipments and investigational product shipment.

Assured adherence to good clinical practices, investigator integrity and compliance with all study procedures.

STUDY COORDINATOR

RADIANT RESEARCH INC. January 2010 – March 2013

Planned and coordinated the initiation of research study protocol, and the establishment of operating policies and procedure.

Planned, implemented and maintained data collection and analysis systems in support of research protocol.

Recruited, instructed and coordinated research subjects as appropriate to specific study objectives and work scope.

Ensured the smooth and efficient day-to-day operation of research and data collection activities.

Completed paper and electronic CRF

Reviewed AEs and SAEs and submission of SAEs to IRB as appropriate

Made appointment with patients for study visits

Prepared and ship biological products for analysis

ACCOUNT ANALYST III

FIDELITY INVESTMENTS. July 2004 - January 2010

Act as liaison between brokers, auditors, vendors and other departments on a daily basis to resolve outstanding issues.

Managed departmental needs and day-to-day supervision of project management associates. Provides leadership, coaching, and training

Analyzes, reports, makes comparisons to industry/company benchmarks, determines trends, and prepares cost analyses.

Make presentations, prepared spreadsheets for data analysis; prepare reports with charts and graphs, mailing lists, and ad hoc requests.

Works with stakeholders to manage risk, identify issues and communicates key issues and status back to stakeholders

EDUCATION:

B.S degree in Business Studies at Dallas Baptist University 2010 - 2013

B.S degree in Banking and Finance University of Calabar Nigeria, 1992 - 1996

THERAPEUTIC EXPERIENCE

Cardiovascular (Hypertension and Heart Failure)

Respiratory/Allergy (Chronic Bronchitis)

Endocrinology (Type II Diabetes)

Metabolic (Obesity)

Ophthalmology (Glaucoma and Cataract)

Osteoarthritis (Osteoarthritis of the Knee)

Infectious diseases- (HIV/AIDS)

SKILLS/TECHNOLOGY

EDC

CTMS/iTRAC

IMPACT

IVRS/IWRS

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