Jacob Stodart
Howell,MI
Summary
To obtain a clinical research position with an organization that offers growth based on dedication and proven ability.
Overview
22
22
years of professional experience
Work History
Senior Clinical Research Associate
Johnson & Johnson, Janssen Pharmaceuticals
05.2011 - Current
- Responsible for the support and management of study sites within a geographic area for Phase 2-4 clinical studies
- Partner with members of the Clinical Trial Team to meet established project timelines and ensure protocol adherence
- Independently monitor assigned study sites on a routine basis with minimal supervision
- Identify, evaluate and recommend potential study sites for participation based on feasibility and protocol outline
- Perform source document verification of CRFs according to SOPs and study specific requirements
- Ensure appropriate reporting of adverse events by investigators according to GCP and SOPs
- Train research personnel on the use of electronic data capture and the proper conduct of clinical studies
- Provide timely monitoring reports in accordance with the study monitoring plan
- Attend investigator meetings as needed.
Quality Trainer/Clinical Research Associate
Kforce (FSP For Genzyme)
05.2010 - 05.2011
- Monitor multiple investigational sites in accordance with State and Federal Regulations, Good Clinical Practices and Standard Operating Procedures
- Act as primary liaison between assigned clinical sites and the Clinical Trial Manager
- Discuss protocol design with the site and deliver the appropriate protocol specific training necessary to conduct a study
- Develop and maintain training materials for operational processes, forms and guidelines
- Conduct CRA field training and oversight visits with feedback to the Lead CRA and Project Manager
- Facilitate and document field training with newly hired CRAs
- Provide technical training for CRAs throughout regions on new and existing required programs and equipment
- Ensure CRAs have knowledge of additional sources of support available to them
- Perform source document verification of CRFs according to SOPs and study specific requirements
- Ensure appropriate reporting of adverse events by investigators according to GCP and SOPs
- Train research personnel on the use of electronic data capture
- Provide timely monitoring reports in accordance with the study monitoring plan.
Regionally Based Clinical Research Associate
Covance CRO
06.2009 - 05.2010
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, and other duties as assigned
- Discuss protocol design with the site and deliver the appropriate protocol specific training necessary to conduct a study
- Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
- Communicate with sites on issues related to protocol conduct, protocol violations, regulatory documents, and regulatory requirements
- Training research personnel on the use of electronic data capture
- Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Ensure adherence to protocol and GCP compliance
- Assist with training, mentoring, and development of new employee.
Contract Clinical Research Associate
Kforce (FSP For Merck)
10.2007 - 12.2008
- Responsible for the monitoring of phase II-IV studies with multiple sites across multiple therapeutic areas including cardiology, endocrinology, CNS, infectious disease, and immunology
- Act as primary site contact for investigator site management and for all operational and routine protocol issues in support of clinical research studies
- Discuss protocol design with the site and deliver the appropriate protocol specific training necessary to conduct a study
- Proactively plan, organize, prioritize, and execute job related duties
- Manage 15-20 sites with multiple protocols utilizing a process oriented approach
- Identify new investigators, pre-study evaluations, site initiations, routine monitoring, and close-out visits
- Communicate with sites on issues related to protocol conduct, protocol violations, regulatory documents, and regulatory requirements
- Provide recruitment and retention advice and support to sites
- Liaison between sites and in house personnel
- Identify training needs of personnel at each site and deliver the training while providing recommendations
- Training research personnel on the use of electronic data capture
- Ensure adherence to protocol and GCP compliance.
Contract Clinical Research Associate
Novartis Pharmaceuticals
10.2006 - 04.2007
- Responsible for the monitoring of phase II-IV studies with multiple sites across multiple therapeutic areas including cardiology, pulmonary, CNS and Transplant
- Identified new investigators, performed prestudy evaluations, site initiations, routine monitoring, and close-out visits
- Ensured adherence to each protocol and followed GCP and ICH guidelines
- Responsible for drug accountability and providing support along with recruitment and retention advice
- Recruited, screened and identified sites to execute clinical trial experiments
- Liaison between sites and in house personnel
- Supported new investigators and sites
- Identified training needs of personnel at each site and deliver the training while providing recommendations
- Traveled to team meetings and investigator meetings
- Trained research personnel on the use of electronic data capture.
Transplant Clinical Research Coordinator/Study Monitor
University Of Michigan Health System
09.2003 - 10.2006
- Responsible for monitoring an eight center NIH sponsored adult to adult liver transplant study
- Responsible for all aspects of coordinating multiple studies, including recruiting and enrolling subjects, assessing lab and other test results, completing case report forms and query resolution
- Trained new study personnel on the proper conduct of coordinating a clinical trial according to ICH, GCP, and FDA guidelines
- Collaborated with the finance administrator to develop a budget consistent with the protocol requirements
- Maintained study binders with required regulatory documents required by the sponsor and FDA
- Traveled to team meetings and investigator meetings
- Drafted informed consent documents and IRB applications for internal review according to ICH, FDA, and sponsor guidelines
- Liaison between patients, medical staff, and pharmaceutical companies.
Clinical Nurse - Cardiology
University Of Michigan Health System
08.2002 - 09.2003
- Acted as a patient advocate
- Provided care and medications prescribed by medical doctors
- Educated patients and families about treatments and care given
- Delegated tasks to unlicensed medical personnel
- Handled patient information in a confidential manner
- Collaborated with other healthcare professionals to provide excellent patient care.
Education
Bachelor of Science in Nursing -
Eastern Michigan University
04.2000
Skills
- Good Clinical Practices
- Electronic Data Capture
- Documentation Management
- Adverse event reporting
- Research SOPs understanding
- Trial management
- Site Management
- Quality Assurance
Therapeutic Experience
- Cardiovascular
- Hypertension
- Dyslipidemia
- Coronary Arteriosclerosis
- Cardiovascular Morbidity
- Endocrinology
- Diabetes Mellitus
- CNS
- Obesity
- Multiple Sclerosis
- Pain
- Migraine
- Post-hysterectomy pain
- Infectious Disease
- HIV/Aids
- Staphylococcus Aurous
- Transplant
- Kidney Transplant
- Liver Transplant
- Pancreas Transplant
- Heart Transplant
- Lung Tranplant
- Vaccine
- Herpes Zoster
Knowledge And Experience
- Strong time management, project management, and organizational skills
- State of Michigan nursing license
- Member of the International Transplant Nurses Society
- Windows 2000, XP, Microsoft Word, PowerPoint Presentation, Lotus Notes
- Attended numerous GCP/ICH seminars; certified with Novartis
Publications
- BLINDED NEORAL C2 MONITORING IN DE NOVO RENAL TRANSPLANT RECIPIENTS submitted for presentation at the American Transplant Congress 2004 Kathleen D. Lake, Pharm.D. 1,2, John C. Magee, M.D. 2, Jacob Stodart, BSN 2, Darlene Mclean, RN 1, Thomas M. Annesley, Ph.D. 3 and Diane M. Cibrik, M.D. 1. 1 Internal Medicine, University of Michigan, Ann Arbor, Michigan ; 2 Surgery, University of Michigan, Ann Arbor, Michigan and 3 Pathology, University of Michigan, Ann Arbor, MI
- THE IRON ION-MYCOPHENOLATE MOFETIL CHELATION COMPLEX INTERATION: A Two Phase Pharmacokinetic Study in Renal Allograft Recipients at the University of Michigan Transplant Program. Danielle K. Gelone, PharmD, Jeong M. Park, MS, PharmD, Jacob Stodart, RN and Kathleen Lake, PharmD
Timeline
Senior Clinical Research Associate
Johnson & Johnson, Janssen Pharmaceuticals
05.2011 - Current
Quality Trainer/Clinical Research Associate
Kforce (FSP For Genzyme)
05.2010 - 05.2011
Regionally Based Clinical Research Associate
Covance CRO
06.2009 - 05.2010
Contract Clinical Research Associate
Kforce (FSP For Merck)
10.2007 - 12.2008
Contract Clinical Research Associate
Novartis Pharmaceuticals
10.2006 - 04.2007
Transplant Clinical Research Coordinator/Study Monitor
University Of Michigan Health System
09.2003 - 10.2006
Clinical Nurse - Cardiology
University Of Michigan Health System
08.2002 - 09.2003
Bachelor of Science in Nursing -
Eastern Michigan University
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