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This role requires the contractor to be onsite 3x/week in Waltham, MA.
Position Overview: The CTA position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of investigational clinical studies. The CTA will support the Clinical Trial Managers in day-to-day activities including engaging vendors, starting up and managing clinical trials. The ideal candidate will have keen attention to detail and has the ability both to prioritize and handle multiple tasks effectively in a rapidly growing company environment.
Key Responsibilities:
- Organize/maintain tracking systems and set up tools to support the conduct of a clinical study from start-up to close-out
- Assist with the development and review of clinical documents including protocols, ICFs and clinical study plans
- Schedule and coordinate study meetings, materials and agendas; recording and disseminating decisions and actions
- Coordinate and manage version control of clinical documents, prioritize multiple tasks and/or projects with limited supervision
- Facilitate vendor engagement from RFP distribution through to final contracting and PO set up
- Setup and organize Sharepoint and central study files
- Coordinate training for the assigned clinical study
- Manage study laboratory sample tracking and vendor management support
- Assist in coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages
- Support Clinical Operations team with specific projects
- Effectively communicate with study team members and work closely to address challenges
Minimum Qualifications
- BS/BA degree or equivalent and at least one year experience in clinical operations in Sponsor company with 1+ years strongly preferred
- Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures
- Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations
- Experience with eTMF; ability to directly apply essential document knowledge to file documents
- Effective communication, organizational and interpersonal/team skills
- Proficient in MS Excel, Word and PowerPoint. Knowledge of MS project and SharePoint preferred.
- Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines
- Participate in inter-departmental workgroups to create or enhance processes
- Strong attention to quality/detail
- Good organizational and time management skills
- Willingness to work in a flexible environment
Preferred Qualifications
- Experience with global studies, using an outsourced CRO model
- Experience in clinical drug development with knowledge of First in Human trials
- Experience with regulatory affairs, including IND/CTA submissions
- Experience working on dermatology
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