Clinical Trial Associate

The Role

Reporting to the Director, Clinical Operations, the Clinical Trial Associate (CTA) will administer, maintain, and coordinate the logistical aspects of clinical trials and participate in a variety of clinical activities to support and facilitate the efficient conduct of Third Harmonic Bio’s clinical research programs. The CTA will focus on providing support during clinical study planning, the development and production of timelines, budgets, various study plans, throughout the duration of the assigned clinical trial(s). They will adhere to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMA, GCP, and ICH guidelines. 

Responsibilities

• Provide support for the initiation of clinical trials that will include liaising across various departments within the organization as well as outside the organization with contracted vendors on such tasks as IRB submissions, regulatory document collection, CTA finalization, coordination and shipment of study supplies, and internal regulatory approval for the release and shipment of study drug.
• Provide continued project maintenance support for ongoing clinical studies. This includes liaising cross-functionally across various departments within the organization as well as outside the organization with contracted vendors on such tasks as continuing IRB review, regulatory document up-dates, vendor management of the eTMF in collaboration with the vendor, auditing the eTMF, coordinating shipment of study supplies and subsequent shipments of study drug.
• Assists with review and tracking of regulatory documents at trial start-up, during maintenance and study closeout.
• Manage the set-up of the eTMF for new studies at study inception.
• Files and maintains documents for all clinical trials in the eTMF (Trial Master Files) and internal document management system as appropriate.
• Participates in file audits by study team and CQA.
• Assists Clinical Operations staff and CRAs with file QC and reconciliation on an on-going basis and at study close.
• Ensures files are inspection-ready
• Assists with CRF, query resolution, and ancillary document tracking
• Ensures files are prepared and documented for off-site archiving; tracks off-site files for department
• Handles miscellaneous study-related tasks as assigned by supervisor.
• General tracking including enrollment, drug supply, monitoring visits and associated reports, site payments, etc.
• In collaboration with Legal and the study team, assist with contract generation and management.
• We value in person collaboration and are looking for someone with a desire and ability to be in the Cambridge office on a routine basis.    

Required Qualifications

• Bachelor’s degree with 1–3 years’ clinical research operations experience is required.  Experience in the life sciences industry is preferred. 
• Comfortable partnering within internal clinical sub-team including interactions with clinical development colleagues (medical monitors, CPMs, Supply chain, data management), and cross-functionally, including CMC, translational, PK and Regulatory.
• Experienced managing relationships and workflows with CROs, vendors and sites.
• Proficient in using Microsoft Office applications
• Exhibits professional communication skills both verbal and in writing including good command of English language
• Exhibits attention to detail; Ability to prioritize tasks and remain flexible in a fast-paced environment
• Works well in a team environment while maintaining initiative and reliability

The salary range for this role is $77,000-$89,000.