Eric Synatschk Email & Phone Number

St Paul, MN, US

• Direction, planning and initiation of clinical studies
• Operational responsibility for ongoing clinical studies including fiscal oversight, study timelines through completion of the clinical study report
• Direct the development of written documents, such as: study protocols, reports, abstracts, peer-reviewed literature and other relevant documents
• Develops relationships with investigators and key opinion leaders
• Tracks project information including patient enrollment, monitoring visits, completion of reports and budgets
• Set-up and coordination of all activities for service consultants/CROs

San Antonio, TX, US

• Direction, planning and initiation of clinical studies
• Operational responsibility for ongoing clinical studies including fiscal oversight, study timelines through completion of the clinical study report
• Direct the development of written documents, such as: study protocols, reports, abstracts, peer-reviewed literature and other relevant documents
• Develops relationships with investigators and key opinion leaders
• Tracks project information including patient enrollment, monitoring visits, completion of reports and budgets
• Set-up and coordination of all activities for service consultants/CROs

Rockville, MD, US

Management of International Studies and CROsDevelopment of study protocols and associated documentsDevelop and maintain department SOPs

Morrisville, NC, US

Dallas, TX, US

Assist in planning departmental activities by helping to determine priorities of projects.Work on protocol development as well as design study specific documents.Work with sites to begin development of study budget / contracts.Assist Quality Assurance group in the closure of open CAPAs.Continue to perform all responsibilities of a Clinical Research.

Perform site pre-qualification visits to determine suitability of sites for participation in clinical trials.Write data management and monitoring plans, SOPs, CRFs, draft protocols and literature review summaries.Responsible for registering all current and future clinical trials on clinicaltrials.gov and posting resulting data.Training and coaching of all.

Perform initiation, study staff training, monitoring and close-out visits for multiple sites in accordance with Standard Operating Procedures and the Monitoring Plan, as well as FDA and IRB guidelines.Monitor multiple sites across the country conducting various protocols to ensure that studies are carried out per protocol and are compliant with ICH.

Tirat Carmel, Haifa, IL

Perform initiation, study staff training, monitoring and close-out visits for multiple sites in accordance with FDA and IRB guidelines.Validation of Oracle EDC system and trouble-shooting for sites in the United States.Continue to perform all responsibilities of Central Files Assistant.

Tirat Carmel, Haifa, IL

Developed filing system in order to bring company into GCP compliance in the event of an FDA audit.Assist in IDE, 510k and PMA submissions.Started monitoring clinical sites in May of 2005 and maintained clinical database for all sites.Developed working procedures for new Oracle EDC system

Attended GCP training and several continuing education courses.Assisted research coordinators with multiple tasks on several studies.Developed extensive knowledge of EDC system (Study Manager); worked to determine software issues with new version, trained research coordinators on its use and helped to enter study data into system.Assisted in a chart review.

Master Of Science, Clinical Research Management

Bachelor Of Science, Biology