390 Stovall St SE #3302 Cell: ail: cs115bdf6@westpost.net Chomeka E.

Sims, MS

(404) 276-9277

Atlanta, GA 30316

Em

Summary A highly experienced Project Manager with considerable National/Global e xperience within the CRO environment and academic clinical research environment. Key therapeutic experiences are inclusive of all phases (I-III) are within the Oncology, Dermatology, Cardiology, Pediatrics, Nephrology, Hematology, Pain and Neurology (NICHD studies). Managerial Project Management Experience -Managed multi-department study teams on more than 25 various clinical trials Lead Research Specialist - Managed and supervised all laboratory operations -Radioactive usage bookkeeping, NRC & OSHA regulations -Data collection, organization and presentation -Interviewing and training new employees, visiting summer medical students and work study students Core Competencies MS Office (including Project) CPRS VELOS database system training Oracle Clinical database VistaImaging WebEx eDM database VISN 7 VISTA Citrix SAS Reader/Viewer system (for VA Sharepoint Medical Systems) Professional -Successfully aided in winning a multi-million dollar contract wi th a large biotech firm to manage their clinical Achievements trial -Successfully completed three clinical trials (each over a year in duration) from study start up to study close out -Successful fast tracked promotion from data coordinator to project manager a t just 6 months with CRO Professional Experience Jan 2008 - Premier Research Group (internationally based CRO) Marietta, GA Dec 2010 Biometrics Project Manager Successfully managed over 25 clinical trials, completing 3, managing over 10 m ulti-department study teams domestically and internationally, and successfully represented the company in ov er 10 bid-defense, capabilities, investigator and kick off meetings. -Designed, communicated and implemented project plans and coordinated a multi department project team, managing project timelines and study budget contract terms to meet every expectation for all Sponsor-contracted activities involving Biom etrics. -Served as a liaison for clinical project managers, department leaders and Spons or, assisting with quality control review and ensuring PRG SOP compliance. -Managed and participated in internal and off-site kick off meetings, proposal defense meetings and Investigator meetings. -Administrated and archived all project-related correspondence. -Familiarized with the drug development process, site study procedures, clinical

monitoring functions, drug safety and regulatory affairs, data flow, statistica l analysis, FDA regulation and PRG SOPs

Jun 2007 - Jan 2008 Premier Research Group Marietta, GA Project Data Coordinator Successfully managed over 10 clinical projects in varying therapeut ic areas, working closelywith the project manager, data management team and stud y sponsor and vendors. -Served as liaison for project manager and da ta management staff -Coordinated specific study activities including query generation and management that maintained data accuracy and integrity within the specific protocol compliance -Executed and tes ted database software, by making recommendations for program modifi cations, generation or resolution -Performed QC of activities and su mmary before executing database lock complying with current compan y SOPs July 2004- Emory University School of Medicine Atlanta, GA Jun 2007 Winship Cancer Institute, Clinical Trials Office/Atlanta VAMC Clinical Research Coordinator, Senior Successfully managed over 25 Oncology stage III and IV clinical trials, mastere d phlebotomy training given on site, and successfully completed a major NSABP sponsor site audit. -Handled or assisted with administrative activities associated with the conduct of clinical trials -Maintained data pertaining to research projects, completed source documents/cas e report forms, and performed data entry -Conducted patient recruitment, and developed and conducted patient and family education accordingly -Attended and presented at study meetings -Ordered medications and lab kits for study and maintained equipment and supplie s -Reviewed medical records and/or conducted screenings for recruitment of study participants, performed interviews and QOL questionnaires -Collected study specimen according to protocol which may include phlebotomy, processing, and preparation for shipping -Coordinated services, scheduled procedures, created and maintained case package s, and monitored charges -Followed up with project participants in accordance with established standards and protocols and ensured project was administered according to research protocol -Served as project liaison to other departments, outside organizations, governme nt agencies and product representatives -Performed quality assurance and tracked regulatory submissions October 2002- Emory University School of Medicine Atlanta, GA July 2004 Winship Cancer Institute Lead Research Specialist Successfully managed a biomedical research lab performing cell tissue culture and molecular biology Techniques (i.e. RT-PCR, Northern blots, DNA purification assay) and trained m any interns and medical students.

-Led in many disciplines towards the ongoing research of an anti-carcinogenic agent targeted against prostate cancer both in vitro and in vivo (animal studies (mice model) June 1998- Emory University School of Medicine May 2002 Department of Orthopaedics Medical Research Specialist Decatur, GA

-Led and assisted in many disciplines towards the ongoing research in genetic bo ne regeneration by analyzing the character of a novel osteoinductive gene discovered in the laboratory. Education August 2002 Georgia State University M.S. Biology (Biochem/Molecula rGenetics) Nonthesis Review Title: A Review of Therapeutic Cancer Vaccines Used in Breast a nd Ovarian Cancer Summer 2002 Morehouse School of Medicine Summer Program Participant March 1998 Georgia State University B.S. Biology