Sr. Clinical Trial Coordinator

Principle Duties and Responsibilities:

• Plan, coordinate, and arrange study communications and critical meetings on and off-site with both internal and external attendees.  Responsible for drafting Meeting Agendas and detailed Meeting Minutes for review and approval by Clinical Project Manager/Clinical Program Manager.
• Set up, update, maintain and close Trial Master Files.  Assures currency and accuracy of required clinical trials documents (i.e. CVs Medical Licenses, Laboratory documentation, Financial Disclosures, Investigator Agreements, etc.).
• Maintain project-specific regulatory document inventory systems which include a precise quality check (QC) process when documents are received.
• Maintains clinical grant tracking database for each study, generates periodic reports on status of grant payments and resolved payment inquiries from investigator sites.
• Communicate with investigator sites on collection of regulatory documents, Institutional Review Board submissions, and follow-up visit reminders as directed by Clinical Project Manager/Clinical Program Manager.
• Create, populate, review, approve, distribute and track study materials as assigned by the Clinical Project Manager and Clinical Program Manager.
• Accountable for accurate organization and maintenance of filing systems and tracking departmental documentation.
• Liaison to clinical and multifunctional teams to resolve issues with submitted essential documents required for trial activities.
• Create study materials, including newsletters, study templates, etc. under the direction of the Clinical Project Manager and Clinical Program Manager.
• Actively participate and contribute ideas in the development of department initiatives and goals that will make a difference in the efficiency and effectiveness of clinical operations.
• Plan, organize and perform a wide variety of responsible clerical duties.
• Provide general office support of technical and non-technical nature.
• Source and distribute study supplies.
• Regularly interact with high-level internal and external clients to coordinate the accomplishment of business needs.
• Support efforts for and/or prepare a variety of correspondence and complex PowerPoint presentations.
• Supports the team to ensure timely invoice processing
• Under guidance of Clinical Operations management, interact with internal and external clients to coordinate the accomplishment of business needs.