Clinical Research Management

Robinson Ogunyemi, BS, MS

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

Pittsburgh, Pa 15221

Phone: 412-***-****

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

Objective: Seeking to utilize my experience in clinical research to coordinate, monitor and

manage all aspects of clinical studies in accordance with ICH Good clinical practices, FDA

guidelines, local regulation and the standard operating procedures of your establishment.

Therapeutic Experience

Oncology: Breast cancer, Prostate, Leukemia (Phase II and III),

Cardiovascular: Hypertension, Stroke, and Cholesterol Control (Phase II and III),

Endocrinology: Diabetes and Obesity (Phase II, III)

Infection Disease: HIV

Professional Experience

Contract International, Raleigh, NC (ON Assignment with AstraZeneca)

Clinical Research Associate –Feb, 2010-Present

• Responsible for all aspects of study site monitoring including routine monitoring and

close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation

visits, liaise with vendors; and other duties as assigned

• Responsible for all aspects of site management as prescribed in the project plans General

On- Site Monitoring Responsibilities

• Ensure the protection of study patients by verifying that informed consent procedures and

protocol requirements are adhered to according to the applicable regulatory requirements

• Complete process of Serious Adverse Event (SAE) reporting, process production of

reports,narratves and follow up of SAEs

• Prepare accurate and timely trip reports

• Ensure the integrity of the data submitted on Case Report Forms(CRFs) or other data

documented review

• Assist with training, mentoring and development of new employees,e.g. co-monitoring

• Responsible for all aspects of registry management as prescribed in the project plans

• Ensure the resources of the sponsor and PRA are spent wisely by performing the

required monitoring tasks in an efficient manner according to SOPs and established

guidelines, including managing travel expenses in an economical fashion according to

PRA travel policy

• Motivated site staff to reach goals, developed successful, professional rapport with site

staff, also instructed investigator site staff in their responsibilities and ensure compliance

with GCP and ICH Guidelines

•

UPMC of Braddock, PA June 2007-June 2009

As Patient Care Support

• Provide emotional support and promote a safe secure and structured environment.

• Help communicating with patients and customers’ needs.

• Contribute to educational, physical and social development of staff retention

• Participates in care center activities / goals to promote staff retention.

Skills

• Expertise in installation database and MS Office tools namely of various software and

operating systems namely UNIX, Windows

• . Expertise in the usage of oracle database and MS Office tools namely word, Power point,

MS-Excel, MS-Access.

• GCP and ICH Guidelines

• Electronic Data Capture: Meta data & Data trak

.

EDUCATION

Clinical Research Professional Development Program

Kriger Research Center

Strayer University, Pittsburgh, PA December 2011

Masters in Healthcare Administration

Point Park University, Pittsburgh, PA December 1992

Bachelors of Science Degree in Business Management

Professional Membership

The Society of Clinical Research Association (SOCRA)

References

Available Upon Request

Contact this candidate