Project Clinical Research

Senior Clinical Research Associate (Regionally Based, USA)

acemor@r.postjobfree.com

Cell Phone: 1-347-***-****

OBJECTIVE

To Secure a position where my Clinical Research and Data Management Skills,

will be used as an added tool in improving the qualities of drug

development and trails monitory.

THERAPEUTIC EXPERIENCE

. Oncology: Breast Cancer (Phase III) and Lung Cancer (Phase II & III)

. Respiratory: COPD (Phases II and III)

. Endocrinology: Diabetes (Type II) (Phase II & III)

EDUCATION

Ambrose Alli University Ekpoma, Nigeria

Bachelors Degree in Medicine (MBBS)

Ambrose Alli University Ekpoma, Nigeria

Associate Degree in Health Educations

EMPLOYMENT HISTORY

Theorem Clinical Research

Regional Clinical Research Associate (Home -Based) (Contract) - April

2011 - Present

. Conducted evaluation, initiation, routine monitoring and close out

visits at each assigned study site, as outlined in the Global

Monitoring Plan (GMP)

. Assisted project teams by ensuring that all data was collected and

submitted within appropriate timelines, and communicated these

timelines to the investigational sites

. Managed time effectively in order to fulfill requirement to meet all

timelines, in both therapeutic work and submission of administrative

documents

. Assisted investigational site in the management of timely query

resolution

. Motivated site staff to reach goals by developing successful,

professional rapport

. Instructed investigator site staff in their responsibilities and

ensured compliance with GCP and ICH guidelines

. Developed recruitment strategies and an enrollment plan with the

investigator and site staff to meet recruitment goals in coordination

with the GMP project recruitment plan

. Identified and evaluated potential investigational sites, documented

and routed appropriately to the central investigator database

. Tracked and monitored enrollment at the sites, initiated additional

recruitment strategies as required

. Made recommendations to close out non-enrolling sites when enrollment

strategies were exhausted

. Worked as an integral team member with respect to quality, integrity,

timeliness, and cost effectiveness when monitoring, and in all other

aspect of job-related responsibilities

SWISS PHARM NIGERIA LIMITED (SWIPHA) LAGOS, NIGERIA

Regional Clinical Research Associate (Contract) - Feb 2009 - 2011

. Conducted Site evaluation, initiation, routine monitoring and close

out visits at each assigned study site as outlined in the Global

Monitoring Plan (GMP)

. Co-monitor with junior CRA's, in reporting and monitoring and Data

Management,

. Inputs and Maintain electronic site management systems

. Monitoring new instruments for assessing the psychosocial Profile of a

drug in diabetic patients.

. Managing time effectively in order to fulfill requirements to meet all

timelines in both therapeutic work and submission of administrative

documents

. Assists investigational site in the management of timely query

resolution

. Training investigator site staff in their responsibilities and ensure

compliance with GCP and regulations of government agencies guidelines.

. Completes Reports to quality standards within company specified

timelines.

. Developing recruitment strategies and an enrollment plan with the

investigator and site staff to meet recruitment goals in coordination

with the GMP project recruitment plan.

. Assists project teams by ensuring that all data is collected and

submitted within appropriate timelines, and communicates these

timelines to the investigational sites.

PROFESSIONAL ASSOCIATION

. Association of Clinical Research Professionals

OTHERS

. FDA Inspection

. GCP

COMPUTER: EDC SKILLS

. Professional Microsoft Office Application (Access, Excel, Power point,

word, publisher and project etc..)

. Inform Phase Forward

. Oracle (OC-RDC)

. Medi-data Rave

. Data Lab

REFERENCES: Furnished upon request

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