Project Clinical Research
Resume:
Bret D. Barnard, MA
Cincinnati, Ohio 45223
************@*****.***
EDUCATION
Master of Arts, Research Design and Quantitative Analyses
The Ohio State University, Columbus, Ohio.
Bachelor of Science, Psychology
Fordham University, Bronx, New York
EMPLOYMENT HISTORY
RPS, Inc., Fort Washington, Pennsylvania 06/2012 – 09/2012
Regional Senior Clinical Research Associate
- Regionally-based, Cincinnati, Ohio
- Completed project activities associated with monitoring functions of Phase III-IV clinical research trials.
- Participated in training of new CRAs and new project team members, CRA development standards.
- Maintained communication with project team members while working independently from home office.
- Traveled throughout the United States to perform investigator site management activities including adherence to all applicable regulatory guidelines, standard operating procedures, protocol guidelines, and the Food and Drug Administration (FDA) for compliance to Good Clinical Practices/International Council of Harmonization standards (GCP/ICH).
PPD, Inc., Wilmington, North Carolina 04/2008 – 02/2009
Regional Senior Clinical Research Associate/CRA Specialist
- Regionally-based, Cincinnati, Ohio
- Completed project activities associated with monitoring functions of Phase III-IV clinical research trials.
- Participated in training of new CRAs and new project team members, CRA development standards.
- Maintained communication with project team members while working independently from home office.
- Traveled throughout the United States to perform investigator site management activities including adherence to all applicable regulatory guidelines, standard operating procedures, protocol guidelines, and the Food and Drug Administration (FDA) for compliance to Good Clinical Practices/International Council of Harmonization standards (GCP/ICH).
- Developed Case Report Forms/Data Collection Instruments.
Boehringer-Ingelheim, Ridgefield, Connecticut 02/2007 – 08/2007
Regional Senior Clinical Research Associate
- Regionally-based, Cincinnati, Ohio
- Completed project activities associated with monitoring functions of Phase III-IV clinical research trials.
- Maintained communication with project team members while working independently from home office.
- Traveled throughout the Eastern United States to perform investigator site management activities including adherence to all applicable regulatory guidelines, standard operating procedures, protocol guidelines, and the FDA (GCP/ICH).
- Assisted in creation of CRFs.
Covance, Princeton, NJ 11/2005 – 11/2006
Senior Clinical Research Associate
- Regionally-based, Cincinnati, Ohio.
- Completed project activities associated with monitoring functions of Phase III-IV clinical research trials.
- Responsible for monitoring clinical trials within an assigned geographic region.
- Maintained communication with project team members while working independently from home office.
- Responsible for training and evaluation of less experienced team members.
- Performed site management including direct communication with sites as the primary contact to oversee collection and documentation of all site regulatory documents, timely completion of all site reports and tracking systems, and creation and maintenance of trial master file.
- Traveled throughout United States to perform investigator site management activities including adherence to all applicable regulatory guidelines, standard operating procedures, the protocol, and the FDA (GCP/ICH).
CTI, Clinical Trials, Cincinnati, Ohio 09/2004 – 10/2005
Lead Senior Clinical Research Associate
- Completed project activities associated with monitoring functions of Phases I-IV transplant clinical research.
- Responsible for training and evaluation of less experienced team members.
- Traveled throughout the United States to perform investigator site management activities including adherence to all applicable regulatory guidelines, standard operating procedures, the protocol, and the FDA (GCP/ICH) as Lead CRA.
- Performed site management including direct communication with sites as the primary contact for overseeing assigned CRAs as the lead CRA, collection and documentation of all site regulatory documents, timely completion of all site reports and tracking systems, and creation and maintenance of trial master file.
- Developed Case Report Forms/Data Collection Instruments.
Aventis Pharmaceuticals, Inc., Bridgewater, NJ 01/2003 – 09/2004
Regional Senior Clinical Research Associate
- Regionally-based, Cincinnati, Ohio
- Completed project activities associated with monitoring functions of Phase I-IV clinical research trials.
- Acted as liaison for use of Oracle-based database to fellow CRAs.
- Traveled throughout the Eastern United States to perform investigator site management activities including adherence to all applicable regulatory guidelines, standard operating procedures, the protocol, and the FDA (GCP/ICH).
- Acted as primary sponsor contact for sites including, collection and documentation of regulatory documentation, Adverse Event and Severe Adverse Event reporting, maintenance of Investigator Study File, and patient recruitment.
- Created Case Report Forms/Data Collection Instruments.
PRA International, Inc., McLean, VA 05/2002 – 01/2003
Regional Senior Clinical Research Associate
- Regionally-based, Cincinnati, Ohio
- Completed project activities associated with monitoring functions of Phase III-IV clinical research trials.
- Traveled throughout the United States to performed investigator site management activities including adherence to all applicable regulatory guidelines, standard operating procedures, the protocol, and the FDA (GCP/ICH).
- Acted as primary sponsor contact for sites including, collection and documentation of regulatory documentation, AE/SAE reporting, maintenance of Investigator Study File, and patient recruitment.
- Created Case Report Forms/Data Collection Instruments.
Kendle International, Inc., Cincinnati, OH 10/1998 – 05/2002
Clinical Research Associate II (06/2000 –05/2002)
- Completed project activities associated with monitoring functions of Phase I-IV clinical research trials.
- Performed investigator site management activities including adherence to all applicable regulatory guidelines, standard operating procedures, the protocol, and the FDA (GCP/ICH).
- Assisted in site management activities including, collection and documentation of regulatory documentation, AE/SAE reporting, maintenance of Investigator Study File, and patient recruitment.
Clinical Research Associate I (05/1999 –06/2000)
- Completed project activities associated with monitoring functions of Phase III-IV clinical research trials.
- Performed investigator site management activities including adherence to all applicable regulatory guidelines, standard operating procedures, the protocol, and the FDA (GCP/ICH).
- Assisted in site management activities including, collection and documentation of regulatory documentation, AE/SAE reporting, maintenance of Investigator Study File, and patient recruitment.
Clinical Programmer/Analyst (10/1998 –05/1999)
- Mapped final clinical trials data from Oracle database to sponsor specifications utilizing SAS software.
- Worked with sponsors, project managers and data managers to establish dataset specifications and standards.
- Analyzed data to ensure quality and integrity
- Created customized data checks and data collection instruments for sponsors, project managers and data managers.
THERAPEUTIC EXPERIENCE
Cardiovascular/Pulmonary (hypertension, pulmonary arterial hypertension, percutaneous coronary intervention, acute ischemic stroke, idiopathic pulmonary fibrosis), Dermatology (urticaria), Endocrine (diabetes mellitus, hypoglycemia, hyperglycemia), GI /Hepatic (Irritable bowel, spastic colon, polyps, hepatitis A, B, C and D, liver transplant, ulcerative colitis), Infectious Disease (sinusitis, sepsis), Immunology (seasonal allergy, rheumatoid arthritis, transplant-organ/graft vs. host rejection and prevention, vaccines-childhood), Hematology (deep vein thrombosis, embolism), Musculo-Skeletal (acute/chronic pain), Nephrology/Urology (kidney transplant, kidney disease/nephritis, shunts and stents), Neurology/Psychiatric (fibromyalgia, painful diabetic neuralgia, post herpetic neuralgia, osteopenia/osteoporosis), Oncology (lung, breast).
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