Clinical Project Coordinator

Gaithersburg, MD 20878

Posted: 11/15/2018 Industry: Other Area(s) Job Number: 32525

Clinical Project Coordinator

Responsible for supporting Clinical Operation Team members with the tasks associated with implementation and conduct of clinical studies. Maintain trial master file, study site records and files and ensure compliance with applicable SOPs.   Create, implement, and maintain systems to track study metrics and general information (ex. OPAL and IMPACT, etc.).   Coordinate generation of study metric reports and action logs.   Review of essential study documents.   Process study-related documents and materials - to include collation, filing, routing coordination of third-party provider document shipments.   Initiate contract/budget requests and track ongoing status. Schedule team meetings and prepare agendas and minutes.   Prepare and distribute study-related correspondence.   Organize and ship study supplies to clinical sites.   Participate in identification and selection of clinical study sites, including conducting searches of web-based databases.   Develop study specific procedures and tools.   Assist clinical operations team with study management.   Assist in the clinical trial insurance process. Track approvals, revisions and renewals of certificates  

QUALIFICATIONS 

Qualified candidates will demonstrate the ability to coordinate and prioritize multiple tasks, have good computer skills, and practical clinical trial experience.
• Bachelor’ s Degree preferred 
• 1-3 year’ s clinical trial experience and at least 1 year experience in an office or laboratory environment 
• Professional demeanor and ability to work as a team member
• Experience with Microsoft Office Suite (Word, Power Point, Excel) 
• Ability to coordinate and prioritize multiple tasks 
• Demonstrated verbal and written communication skills
• Demonstrated interpersonal and problem solving skills
• Proactive approach and the ability to act independently, or as part of a diverse team
• Understanding of ICH, GCP and relevant regulatory requirements 
• Familiarity with drug names, diagnoses and medical/research terminology
• Ability to work as part of a global team 
• Willingness to travel to attend periodic meetings.   Percentage of Travel: 10%
 
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