Project Management

Stephanie Omburo

*** ******* ******, ****** ****, NJ, USA

Tel: 201-***-****

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

Employment History

Covance Clinical Development Services, Princeton, NJ, USA – Jun. 2011 – Present

Clinical Research Assistant – Jul. 2012 – Present

• Act as contact for project team and study sites

• Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management

• Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data

• Assist with the management of study supplies and organize shipments

• Create, update, track, and maintain study-specific trial management files, tools, and systems.

• Assist the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators’ meetings)

• Co-ordinate meetings with clients, investigators, and project team, including taking minutes.

• Ensure compliance with Covance SOPs, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work

• Provide input in writing Monitoring Conventions as assigned

• Assist in submissions and notifications to Ethics Committees and Regulatory Authorities

• General On-Site Monitoring Responsibilities:

o Assist Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability)

o Initiate, monitor and close out clinical investigative sites under direct supervision from Clinical Research Associates 1 and 2, Sr. Clinical Research Associates, Project Managers or Project Directors

• Perform other duties as assigned by management

Associate, Global Site Services – Jun. 2011 – Jul. 2012

• Collected the required investigator and local contact information to enter into Trial Tracker® Site Information Module

• Where applicable distributed study specific information directly to investigative sites or to local monitors

• Provided data entry support to Global Site Services; entered feasibility information or investigative site information (study supply shipping information / clinical study locations / site personnel)

• Liaise with investigative sites to facilitate retrieval of site start-up documentation

• Served as the primary contact between investigative sites during start up activities

• Assisted in the collection, review, processing and tracking of regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP and ICH guidelines and the Investigator Package Plan

• Followed-up with investigative sites regarding document completion/submission

The Center of Infectious Disease Dynamics, State College, PA, USA – May 2008 – May 2010

Laboratory Technician – May 2009 – May 2010

• Maintained solutions and materials in the lab

• Conducted experiments such as: plasmid preps, gel extractions, bacteria cultures

• Assisted in ongoing projects

• Performed individual research projects

Student Intern – May 2008 – May 2009

• Data entry and organization

• Assisted post-graduates with ongoing research

Center of Academic Achievement at Penn State, Schuylkill, PA, USA – Aug. 2007 – May 2008

Peer Tutor – Aug. 2007 – May 2008

• Assisted in student learning course material in biology, trigonometry, chemistry, and English

• Documented the progress of tutee’s education to course professors

Therapeutic Experience

• Nephrology: Renal Impairment, (PHASE(3))

• Neurology: Schizophrenia, (PHASE(2))

• Oncology: Pancreatic Cancer, (PHASE(2))

• Pulmonary: Asthma, (PHASE(3,2))

Language Capabilities

• English

Education

• Masters of Health Science, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

• Certificate in Vaccine Science and Policy, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD,USA

• Certificate in Good Clinical Practice, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

• Bachelors of Science, Biology, Pennsylvania State University, University Park, PA, USA

Appendix I

Publications, manuscripts, abstracts, and/ or presentations

Marks, M.D., Tian, L., Wenger, J.P., Omburo, S.N., Soto-Fuentes, W., He, J., Gang, D.R., Weiiblen, G.D, and Dixon, R.A. (2009). Identification of candidate genes affecting delta (9)-tetrahydrocannabinal biosynthesis in Cannabis sativa. J Exp Bot 60, 3715-3726

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