Highly experienced clinical research professional with considerable experience within the CRO, Pharmaceutical and Biotech environment. Key experiences are within Analgesia, Hepatic and Biliary Disorders, Immunology, Oncology, Fertility device, Psychiatry, PONV and Pulmonary/Respiratory.
Managed clinical trials for Phases II, IIb, and III, drug development programs.
Electronic Data Capture Proficiency
Microsoft Office Proficiency: Excel, Word, PowerPoint and Outlook
Reviewed and approved invoices for vendor and site payments.
Reviewed and approved monitor trip reports, tracked ongoing issues and query resolution.
Escalating compliance and study issues to Study Director.
Identified and resolved vendor and client issues.
Reviewed eCRFs for protocol violations/deviations.
Interacted with data management, project management, global company departments and regulatory departments for all study updates.
Developed and updated strategic documents such as Recruitment Plans and Monitoring Guidelines.
Managed cross-functional project timelines, resource capacity vs. availability, and budget.
Drove the development and updates of strategic documents such as Recruitment and Trial Plans and Monitoring Guidelines.
Analyzed timeline, resource, and budget information in order to conduct scenario planning, contingency planning, risk assessment and management, problem solving, and decision-making.
Assumed full responsibility for managing specific aspects of the project, identified issues and facilitated problem solving, contingency planning and decision-making.
Conducted study site electronic case report form training, validation and site certification
Job Title: Clinical Research Scientist II - Jan. 2005 - June 2006
Job Title: Clinical Trial Manager II - May 2002 - Dec. 2004
Job Title: Clinical Research Associate - Sept. 2001-May 2002
Job Title: Site Support Specialist/ In-house CRA
Job Title: Project Assistant II - Apr. 1999 - Aug. 2000
Collected and reviewed regulatory documents for IRB submission
Tracked protocol deviations and subject enrollment
This is a real resume for a Senior Clinical Research Associate in Neptune, New Jersey with experience working for such companies as Premier Research, Inc Research, Gracian Research. This is one of the hundreds of Senior Clinical Research Associate resumes available on our site for free. Use these resumes as templates to get help creating the best Senior Clinical Research Associate resume.
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