Integra Research, LLC

Integra Research, LLC (Nashville, TN)

Principal, Contract Clinical Research Consultant

July ​2011 - present

 

A consulting company providing a variety of services to the pharmaceutical/biotech industry/CRO/ARO. Clients include Hoffmann-La Roche, MHICC, C5 Research, Berman Center for Outcomes and Clinical Research, Julius Clinical Research, George Institute, Synteract HCR, Intellikine, Millennium: The Takeda Oncology Company, HeartWare Inc., Sucampo Pharmaceuticals, ARMO BioSciences, Novavax, Can-Am Research, Medtronic, TARIS Biomedical, Algenis, Syreon, Abiomed, Clinlogix, Barrington James, UroGen, Highline Sciences, Clovis Oncology, Visualize Health, Gritstone Oncology, Boehringer-Ingelheim, Alethia Biotherapeutics, Kezar Life Sciences, Sumitomo Dainippon Pharma Oncology, PharPoint Research, Inc, Minerva, F-Star, Promedica International, MEDIcept Inc. and COUR Pharma.

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Genitech, LLC (Nashville, TN)

Healthcare Efficiency through Technology

​March 2012 - December 2012

 

Trainer for electronic medical record platform - PrimeSUITE by Greenway

 

Celgene Corporation (Summit, NJ)

Lead, Senior Clinical Research Associate

​November 2005 - March 2012

 

Lead Clinical Research Associate: Served on a study team as the lead clinical research associate and monitoring representative; developed the study monitoring plan and subsequent revisions; reviewed, track and acknowledge monitoring visit reports; managed and tracked monitoring site visits to ensure quality monitoring; ensured adequate monitoring resources, ensured field monitors (FM) were trained properly in the study requirements; conducted training for newly assigned FMs; tracked and reported critical issues to study team; participated in CRF and protocol review process; attended, participated and presented at Investigator Meeting; performed field assessments of Celgene and CRO FMs; developed study-specific tools for Investigative sites and FMs; conduct weekly FM teleconference calls

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Senior Clinical Research Associate: Hand-picked to be a part of Celgene’s first regional monitoring group (RMG) to develop working procedures, standard operating procedures and process for the RMG and clinical operations; worked on clinical trials in areas of unmet medical needs; Clinical Research Associate on multi-center phase I-III clinical research studies; performed pre-study, site initiation, interim and closeout visits in the role of primary CRA and as clinical mentor; assigned to multiple protocols and multiple indications; ensured investigative sites’ adherence to GCP, ICH guidelines, and local regulations; serve as the liaison between Celgene and assigned sites built relationships to ensure timelines were met, Built effective and positive relationships with Principal Investigators; conducted pre-study visits through close-out visits at investigative sites; conducted source document verification of CRFs against medical records, investigational product accountability, review investigator study file(s) and reconcile to trial master file(s), performed safety reviews/SAE reconciliations; created trip reports, confirmation/follow-up correspondence and telephone contacts for assigned sites

and kept information in the CTMS current; maintain calendar; evaluated data query trends and interact with study team in order to improve data quality; ensure issues

of data quality are escalated and resolved with study team and CQA; Identified site issues, ensured proper escalation, if necessary, and ensured resolution; CTMS superuser to FMs; responded to audit findings; attended and participated in study team meetings; maintained annual training records; identified and evaluated potential investigators for future Celgene studies; scheduled travel following Celgene’s travel policy, and submit expense reports in an accurate and timely manner; developed eCRFs for critical Phase III study; authored “A Day in the Life of a Clinical Research Coordinator” presentation to train interdepartmental functions

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PPD, Inc. (Wilmington, NC)

Senior Clinical Research Associate

​May 2001 - October 2005

 

Clinical Research Associate on multi-center phase II-IV clinical research studies; resourced directly to pharmaceutical companies operating under their SOPs, reported directly to their study management, utilized their CTMS and trip report templates; participated and presented at investigator meetings for assigned studies and assisted in investigator recruitment; evaluated, initiated, monitored and closed out sites according to applicable Standard Operating Procedures (SOPs) and ICH/FDA guidelines; reviewed case report forms for completeness, clarity, legibility, conformity to available source documentation, and adherence to protocol requirements; resolved CRF discrepancies and/or clarifications via site visit, telephone, or fax as deemed appropriate for the study; performed drug accountability, ensured prompt reporting of adverse events and verified completeness of critical documents; performed pre-study, site initiation, interim and closeout visits in the role of primary CRA and as clinical mentor

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Innovex, Inc. (Parsippany, NJ)

Nurse Educator for EMR

​January 2001 - May 2001

 

Participated on IKnowMed Project, an electronic medical records (EMR) software system, at the MD Anderson Oncology Clinic in Orlando, FL; primary responsibility was to train office personnel on the use of the software and to enter historical patient medical history into the EMR

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H. Lee Moffitt Cancer Center and Research Institute (Tampa, FL)

Nurse Preceptorship

January 1996 - May 1996

Clinical Research Coordinator

​October 2000 - January 2001

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Nurse Preceptorship: Completed clinical preceptorship in the Intensive Care Unit

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Clinical Research Coordinator: Participated in the conduct of phase III-IV multi-center clinical research studies in the GI Tumor program as a Clinical Research Coordinator; reviewed project-related materials and literature to develop a basic understanding of the protocol and therapeutic areas; duties included patient recruitment, enrollment, study procedures, regulatory, specimen handling, and data entry

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Clinical Pharmacology Services, Inc. (Tampa, FL)

Clinical Research Coordinator

​January 1999 - October 2000

 

Participated in the conduct phase I-IV of multi-center clinical research studies as a Clinical Research Coordinator; reviewed project-related materials and literature to develop a basic understanding of the protocol and therapeutic areas; duties included patient recruitment, enrollment, study procedures, regulatory, phlebotomy, specimen handling/processing/shipping and CRF completion.

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University Community Hospital (Tampa, FL)

Registered Nurse

​August 1998 - May 2001

 

Provided primary patient care in Tampa’s premier heart center in the Coronary Care Unit (CCU), Cardiac Surgical Unit (CSU), pre-cardiac catheterization, post-cardiac catheterization/angioplasty and electrophysiology (EP) lab. Other duties include team leader and clinical mentor.

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Gulf Coast Recycling, Inc. (Tampa, FL)

Health & Safety Coordinator/Occupational Health Nurse

​August 1996 - August 1998

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Responsibilities included OSHA compliance, quarterly monitoring of air quality throughout the entire plant, maintained all employee medical records, worker’s compensation for entire plant, coordinated bimonthly blood draws with local clinic, coordinated all conducted all new employee training and annual re-training, conducted monthly plant-wide safety meetings.