Job Title: Clinical Trial Coordinator

 

Job Duties: Coordinate and support clinical trials across start-up, conduct, and close-out; prepare and submit IRB/IEC applications and amendments; maintain study master files and documentation in compliance with ICH-GCP and applicable regulations; track timelines, enrollment, and visit schedules; oversee data collection and query resolution in EDC/CRFs and assist with PK/PD sample tracking and vendor communications; monitor safety reporting workflows (AEs/SAEs) to ensure timely notifications; liaise with Principal Investigators, research sites, and cross-functional teams to ensure protocol adherence and data quality; assist with development of study tools (source documents, checklists) and prepare periodic status reports for management and stakeholders.

 

Requirement: Master’s degree (or foreign equivalent) in Molecular Biology, Cellular Biology, Biomedical Sciences, Pharmacology, or a related field, and one (1) year of experience

 

40hr/wk, 8-5pm, Send resumes to SciTech Development, Inc., 281 Kercheval Ave, Grosse Pointe Farms, MI 48236. Attn: Andrew Stumpf/CFO

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This notice is being provided as a result of the filing of an application for permanent alien labor certification for this job opportunity.  Any person may provide documentary evidence bearing on the application to the certifying officer of the Department of Labor as follows:

 

United States Department of Labor

Employment and Training Administration

Office of Foreign Labor Certification

200 Constitution Avenue NW

Room N-5311

Washington, DC 20210

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