Contract - Clinical Trial Assistant

CONTRACT - CLINICAL TRIAL ASSISTANT

Job Summary:

The Contrat - Clinical Trial Assistant (CTA) is responsible for providing support to the lead Clinical Trial Manager and the study management team, clinical tracking and document maintenance as applicable to study vendors and clinical trial sites. The CTA will work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in compliance with GBT SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets. The CTA must work well under pressure and can meet multiple and sometimes competing deadlines. The CTA must demonstrate cooperative and professional behavior with colleagues and vendors. The CTA should be able to show flexibility with changing project-specific priorities.

Essential Duties and Responsibilities:

• Performs general administrative functions such as clinical trial tracking, providing logistical support to one or more study management teams (SMTs), scheduling meetings and/or travel arrangements for clinical staff, requesting proposals/contracts from CROs, tracking and managing distribution of non-clinical supplies throughout the course of the study
• Tracks and maintains study information and reports on study progress
• Tracks and provides IRB/IEC submission documentation and other supplementary documentation as appropriate
• Obtains, reviews, processes, and tracks study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.)
• Maintains and ensures the completeness of the Study Level Trial Master File (TMF) in accordance with SOP requirements
• Serves as key central contact for communications, correspondence and associated documentation. Performs duties such as, clinical form design, and filing of correspondence, lab reports, clinical monitoring reports, and other study documents
• Maintains and ensures all documentation is in a state of audit-readiness
• Responsible for collection, dissemination, and/or tracking of regulatory documents as required
• Maintains accurate tracking and reporting of study management data
• Maintains and disseminates basic study tracking information including, but not limited to: Visit Reports, Regulatory Documents, Site Contact Lists, Team Contact Lists, Vendor Lists, and Budget Disbursements
• Manages and tracks Investigational Product supplies for study centers; receives and prepares requests, ships and returns Investigational Product supplies
• Prepares, ships and manages inventory of study related supplies
• Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards
• Gathers investigator and site information (addresses, phone numbers, fax numbers, personnel names and email addresses, etc.)
• Assists in preparing materials for investigator meetings, workshops, and study manuals
• Creates meeting agenda/minute templates and provides drafts of meeting minutes
• Communicates effectively with members of the GBT and vendor project teams
• Other tasks or responsibilities as assigned

Qualifications:

• The qualified candidate will have a Bachelor and/or advanced degree in nursing, biological sciences or related field, or equivalent combination of relevant experience, education or training and previous CTA experience
• She/he will have the following:
• Attention to detail
• Excellent organizational skills
• Effective communication and interpersonal skills
• Ability to efficiently perform multiple tasks and manage changing priorities
• Ability to identify and solve logistical problems
• Ability to work effectively on a diverse team
• Ability to read and understand regulatory documents and Standard Operating Procedures
• Demonstrate proficiency in Microsoft Word, PowerPoint and Excel
• Take direction well