Job Title: Clinical Trial Associate
Location: Metro Boston preferred, hybrid working model
Location: Waltham, MA
Remote Flexibility: 2-3 days/week on-site
Contract Term: 6 months to start; could extend or go perm
Experience required:
- Preference is experience at CRO or small biotech for at least 1-2 years with exposure to clinical sites including site startup and IRBs
- If no experience in CRO, then site experience as a study coordinator
- Larger biotech/pharma is okay if they've engaged directly with clinical sites
- Looking for someone that can work on RFI's out for vendors, phase 1 units, setting up trackers/tools, working with vendors, etc
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
