~ Clinical Research Specialist eager to contribute strong healthcare management background

and well-developed project leadership talents toward actively supporting the employer

 in achieving goals and objectives. ~

 

 

         Advanced knowledge of ICH Guidelines, Good Clinical Practices, Medicare criteria, and IRB policies and procedures to effectively expedite approval process.

         Excellent academic credentials, reputation for unparalleled integrity and commitment to maintaining and enforcing confidentiality, and proven expertise in team leadership.

         Possess a comprehensive professional network of health care providers and physicians.

         Display a collaborative work approach and ability to drive cohesive efforts among all levels of a hospital or health care organization.

         Proficient at preparing compliance documents and obtaining approvals from CRO (clinical research organization) and IRB (Institutional Review Board).

 

Therapeutic Areas:

 

Oncology (kidney cancer; skin cancer; liver cancer; lung cancer; ovarian cancer) Endocrine (Diabetes, Diabetic Peripheral Neuropathy) Infectious Disease (Uncomplicated Acute Influenza) Musculo-Skeletal (Fibromyalgia;  Osteoarthritis) Cardiovascular (Mixed Dyslipidemia, Hypercholesterolemia) Dermatology (Psoriasis) Reproductive (Contraceptive/Birth Control, Dysmenorrhea)

 

 

Vanderbilt-Ingram Cancer Center, Nashville, TN, 2009 to Present

Research Coordinator

         Apply significant organizational skills toward obtaining and processing Regulatory and Investigator documents for study site in accordance with Vanderbilt and sponsor SOPs, GCP and ICH guidelines.

         Expeditiously prepare regulatory documents for Investigator signature and approval by sponsor, CRO, and regulatory agency.

         Complete Vanderbilt IRB submission and informed consents for project research protocols.

         Spearhead full spectrum of research activities within Center and contribute to budget administration.

         Employ strong time management skills to conduct in-house monitoring of studies to ensure audit readiness.

         Promptly report all adverse and serious adverse events from clinical trials.

         Administer eCRF (electronic case report forms) with full accountability for consent forms.

         Actively participate in investigator meetings as sub-investigator.

 

Covance, Nashville, TN, 2006 to 2009

Specialist, Clinical Development Services

         Proficiently administered Confidentiality, Feasibility, Regulatory & Investigator documents for study site activation in accordance with Covance and sponsor SOPs, GCP and ICH guidelines, and Investigator Package Plan.

         Exercised solid leadership talents and interpersonal skills to train new associates, delegate work assignments, and instruct associates in proper use of site information module database.

 

Continued

 

 

Professional Experience continued

 

         Participated in Six Sigma initiatives while navigating study improvement pilot programs to reduce cycle time and cost.

         Partnered with sponsor s legal team in determining, revising, and finalizing contract language.

         Planned, negotiated, developed and managed budgets for multiple trials concurrently.

         Exhibited keen multi-tasking capabilities in preparing investigator payments, assembling new investigator submission packages to Central IRB, and submitting milestone information for weekly analysis.

         Critically assessed and responded to impact of study personnel changes on regulatory documents and impact of study amendments on Informed Consent and other study documents.

         Leveraged excellent communication skills to drive unified efforts among Regulatory Department (Covance, Sponsor or both), Central IRB, and study vendors.

         Advanced from Associate role with Clinical Development Services (2006 to 2008) based on exceptional performance.

 

University of Phoenix, Department of Health Sciences,  Nashville, TN, 2008 to 2009

Associate Professor, Health Care Administration

         Administered curriculum via on-campus and web-based channels, exhibiting considerable strengths in facilitating classroom discussions, delivering lectures, and adapting course content, materials and delivery to optimize relevancy and student comprehension.  

         Drew upon sound analytical skills to evaluate and grade student assignments and papers, while providing mentoring and encouragement where needed.

 

State of Tennessee, Franklin, TN, 2002 to 2006

Case Manager III

• Trained, motivated, supervised, directed and coached several personnel, emphasizing SOP compliance, productivity, accountability, and attentive client service.
• Drafted and submitted consents to the State, oversaw call center operations including reporting of child abuse allegations, and diligently monitored client progress while steering HIPAA compliance.

 

 

MBA, Healthcare Administration C University of Phoenix, Nashville, TN

B.S., Sociology ~ Minor in Psychology C Tennessee Technological University, Cookeville, TN

CCRP Certification

Certified Forensic Interviewer

 

 

Microsoft Office Suite (Outlook, Access, Excel, PowerPoint, Publisher, Word), Adobe Acrobat 9 Pro, Lotus Notes, Trial Tracker, OnCore, Onsemble, PercipEnz, DISCOVR-E, StarPanel

 

 

Member, American College of Healthcare Executives

Member, Cambridge Who s Who 2008-2009 Executives, Professionals, and Entrepreneur Women