Hybrid Clinical Trial Associate – Early Phase

Disc Medicine; Watertown (MA); Hybrid; USD 76,000 - 92,000; Full time

Job summary

Disc Medicine in Watertown, MA, is seeking a Clinical Trial Associate to join a dynamic Clinical Operations team in a hybrid role with both in-office and remote work options. You will support early-phase studies, manage study documentation, and collaborate with CROs and vendors to drive trial execution.

The successful candidate will have a BA/BS, strong knowledge of FDA/ICH GCP, and proficiency in MS Word/Excel/PowerPoint/Outlook, with excellent organizational and communication skills to handle

Qualifications

• BA/BS degree is required.
• Knowledge of FDA and ICH GCP guidelines.
• Proficient with MS Word, Excel, PowerPoint, Outlook.
• Strong collaboration and communication.
• Ability to manage multiple tasks in a fast-paced environment.
• Experience working on project teams.

Responsibilities

• Provide day-to-day support for clinical study activities within the outsourced model.
• Collaborate with CTMs, study teams, vendors and CROs to support trial activities.
• Prepare and coordinate bi-weekly team meetings; manage agendas, slides and minutes.
• Develop and/or review study documentation and essential document packets.
• Contribute to writing/review of protocols, ICFs, brochures, reports and manuals.
• Maintain audit-ready TMF and lead internal TMF quality reviews.
• Track patient samples and coordinate data deliverables with labs/sites.
• Assist finance with invoices and projections.
• Support startup activities with CROs to meet timelines.
• Review monitoring visit reports and close out outstanding items.
• Collaborate across Legal, Finance, Nonclinical, CROs and vendors.
• Maintain trial-related processes/systems with study vendors.
• Develop timelines and align cross-functional deliverables for data cuts.
• Monitor progress and report on budget/timelines.
• Maintain patient trackers and provide real-time updates to the team.
• Initiate ClinicalTrials.gov updates and publications when needed.
• Participate in SOP preparation/review.
• Perform other duties as directed.

Skills

GCP/FDA guidelines

MS Word

MS Excel

PowerPoint

Outlook

Collaboration

Initiative

Organization

Multi-tasking

Teamwork

Education

BA/BS

Tools

MS Word

MS Excel

PowerPoint

Outlook

Job description

Disc Medicine in Watertown, MA, is seeking a Clinical Trial Associate to join a dynamic Clinical Operations team in a hybrid role with both in-office and remote work options. You will support early-phase studies, manage study documentation, and collaborate with CROs and vendors to drive trial execution.

The successful candidate will have a BA/BS, strong knowledge of FDA/ICH GCP, and proficiency in MS Word/Excel/PowerPoint/Outlook, with excellent organizational and communication skills to handle