Clinical Research Medical

Ophthalmic Certified Clinical Research Associate

Accomplished clinical trial manager with extensive experience conducting ophthalmic research studies involving pharmaceuticals and medical devices. Responsible for conducting clinical trials according to GPC guidelines. Results-oriented, enthusiastic individual demonstrating success in Phase I thru Phase III clinical trial management. Track record for obtaining ‘clean’ data while completing projects in a timely manner.

CORE COMPENTENCIES

Source/CRF Verification Regulatory Compliance Protocol Design

SOP Development Site Personnel Training Complete Site Management

Timely/Accurate Site Reports Resolution of Study Site Problems Excellent Communication

PROFESSIONAL EXPERIENCE

THE EMMES CORPORATION 11/2010 – Present

Clinical Research Associate

Working under the National Eye Institute Support project managing ophthalmic clinical trials at the NIH. Monitors data and ensures data entry is complete and consistent between electronic Case Report Forms (eCRFs) and source documents. Creates necessary trial related documents, e.g., Manual of Procedures, Monitoring Plans, Flowsheets and Master Trial Files. Conducts monthly site conference calls and performs site initiation, interim and close-out site monitoring visits. Prepares timely written reports for monitoring visits, including location of problems and deficiencies and recommends remedial actions.

ORA CLINICAL, INC. 05/2010 – 11/2010

Clinical Research Associate

Worked on a contract basis with an ophthalmic clinical research organization managing all monitoring aspects of a dry eye clinical trial. Conduct site initiation visits including personnel training, IRB submissions and interactions, intermediate monitoring visits and close out visits. Performed 100% source document verification along with eCRF verification. Responsibilities also included drug accountability, Adverse Event reporting, sponsor correspondence and regulatory and GCP compliance.

JAZZY JUNQUE, LLC 05/2006 - 02/2010

Owner, Furniture Consignment Store

Owner of an upscale furniture consignment store taking in slightly used furniture and selling it for our clients; handled all accounts payable and receivable, accounted for all inventory, worked with clients and customers in redecorating homes and offices, managed all staff, both full and part time employees, designed and coordinated all advertising

CLINSTUDIES, LLC 07/1999 - 01/2006

Owner, Clinical Research Organization

Ownership of a clinical research organization working with ophthalmic pharmaceutical and device companies. Managed clinical trials involving intracorneal lenses, methazolamide, intraocular lenses, refractive lasers and

dry eye. Provided complete clinical trial responsibilities including: recruiting investigators, coordinating investigator/sponsor and/or FDA meetings as necessary, designing and writing protocols, SOPs, CRFs and

all necessary trial documents, provided data capture, verification and management, identified and resolved project issues affecting the clinical conduct of the trial, developed comprehensive subject recruitment strategies and monitored enrollment to assure milestones were met, performed initiation, interim and close-

out site visits in accordance with SOPs, managed day-to-day clinical operation of assigned protocol(s), activities, provided study statistical analysis, implemented secure study product storage and inventory, managed Adverse Events according to protocol and FDA guidelines.

ROBERT H. MARMER, MD 06/1989 – 06/1999

Clinical Research Coordinator/Medical Staff Supervisor

Supervised all clinical trials conducted in this ophthalmic medical office. Conducted clinical trials involving scleral stents for patients with glaucoma, glaucoma medications, intraocular lenses and ozone for the treatment of retinitis pigmentosa. Responsibilities included: recruiting patients for clinical studies, completing CRFs, training the medical staff to perform study required medical procedures according to study protocols, interfaced with clinical research associates to ensure protocol adherence and valid study data, supervised physicians, nurses and ophthalmic technicians, negotiated site budget and investigator contracts, attended investigator meetings, providing locked study drug storage, prepared IRB submissions. Pharmaceutical and device ophthalmic studies were performed in this office. Assisted with refractive and medical necessary ophthalmic surgeries including, cataract, retinal, glaucoma, enucleations and blepharoplasties.

TREVOR WOODHAMS, MD 02/1986 – 06/1989

Ophthalmic Technician/Medical Staff Supervisor

Worked in this ophthalmic office performing all necessary testing on patients while managing technicians and physicians. I worked with Dr Woodhams to develop a refractive surgery procedure for the treatment of myopia and astigmatism.

PROFESSIONAL ACTIVITIES

• 1999 – 2006 Member of the committee for American Nation Standards Institute developing

uniform standards for conducting clinical trials

• 1998 “Once in a Career” lecture presented at the American Academy of Ophthalmology to physicians profiling a patient with a cancerous tumor on the optic nerve, Atlanta, GA

• 1998 Published article “Ozone Treatment in Retinitis Pigmentosa” Annals of Ophthalmology

• 1997 “Handling the Refractive Surgical Patient” lecture to Piedmont Hospital’s surgical nurses, Atlanta, GA

• 1995 Directed live televised phacoemulsification with intraocular lens implant surgery at the American Academy of Ophthalmology meeting, Atlanta, GA

• 1996 Supported renown ophthalmologist, Slava Fyodorov with refractive surgery on live television, Atlanta, GA

• 2010 Certificate of Completion –Seven Part Series – ICH Good Clinical Practice- Septor

• 2010 Certificate of Completion – National Institutes of Health Protecting Human Research Participants

• 1991 JCAHPO Ophthalmic Assistant Certification

• 1980 Completed Advanced Series for Ophthalmic Medical Assistants (American Academy of Ophthalmology)

• 1976 Ophthalmic Assistance Certification

• 2010 Member Association of Clinical Research Professionals

• 2011 Clinical Research Associate Certification (ACRP)

Contact this candidate