Clinical Trial Associate

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