RemoteLeaf Logo
Log in Sign up

Senior Clinical Trial Associate

1 month, 1 week ago
Anywhere
Senior
Project Coordinator
Project and Program Management
Apply Now
Dianthus Therapeutics

Dianthus Therapeutics

Dianthus Therapeutics is focused on developing advanced complement antibody therapeutics, specifically engineered to provide targeted treatment for patients with significant unmet medical needs, exemplified by their lead product, claseprubart (DNTH103)...

Pharmaceuticals
11-50
Founded 2019
View All Jobs 6

Description

  • Support assigned clinical studies and contribute to project and study deliverables.
  • Coordinate, attend, and help lead study team meetings, including scheduling, agendas, minutes, and documentation.
  • Maintain and generate study trackers and documents such as action-decision logs, storyboards, enrollment trackers, and IRB approval records.
  • Monitor clinical trial insurance and license agreements and work with vendors to keep agreements current.
  • Support the development and review of study documents, including study manuals.
  • Serve as a team super-user or subject matter expert for study-related systems and processes.
  • Manage deliverables and adapt to changing priorities across studies.
  • Support preparation for investigator meetings, PI calls, conferences, and internal clinical meetings.
  • Maintain the Trial Master File to ensure accuracy and completeness in line with the Sponsor Oversight plan.
  • Assist with study budget oversight, including invoice tracking and reconciliation.
  • Participate in vendor selection and management meetings with CROs, IVRS, Central Labs, and other vendors.

Requirements

  • BA/BS degree or equivalent relevant work experience.
  • Prior CTA experience required.
  • Minimum of 5 years of experience working on clinical studies in a pharmaceutical, biotech, or CRO setting preferred.
  • Experience supporting global clinical study teams.
  • Strong interpersonal and communication skills with the ability to work collaboratively across functional teams.
  • Strong organizational and time management skills with excellent attention to detail.
  • Knowledge of global regulatory and compliance requirements for clinical research.
  • Experience with essential documentation for Trial Master Files required.
  • Knowledge of drug development, clinical operations processes, medical terminology, and FDA GCP/ICH regulatory guidelines.
  • Proficiency with MS Office tools, including Word, Excel, SharePoint, and PowerPoint.
  • Experience with clinical trial systems such as CTMS, IRT, and EDC preferred.

Benefits

  • Remote work is available.
  • Opportunity to grow with the organization and receive ongoing development support.
  • Work on potentially best-in-class therapies for severe autoimmune diseases.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

A

Entry Level | Experience Scheduling Coordinator | Remote

Aisle and Abroad Travel & Tourism

Remote Experience Scheduling Coordinator for Deidre supports client scheduling, reservations, and administrative coordination to deliver a seamless service experience in a fully remote setting.

United States Full-time Entry Level Project Coordinator
$25k-$75k
23 minutes ago
A

Event Planning Assistant (Remote)

Aisle and Abroad Travel & Tourism

Deidre is hiring a remote Event Planning Assistant to support event coordination, logistics, and execution from initial planning through completion.

United States Full-time Entry Level Project Coordinator
$45k-$65k
46 minutes ago
Resource Innovations

Energy Efficiency Commercial Project Coordinator

Resource Innovations 251-1K Renewable Electricity

Resource Innovations is hiring a remote Energy Efficiency Commercial Project Coordinator to support utility-sponsored retro-commissioning projects for commercial and industrial buildings across the New England region.

United States Full-time Mid Level Project Coordinator
$85k-$95k
1 hour, 2 minutes ago
Precision For Medicine

In-house CRA I

Precision For Medicine 1K-5K Pharmaceuticals

Precision for Medicine is hiring an In-house CRA I in Serbia, Hungary, Poland, Romania, or Slovakia to support clinical study sites and project teams in the management and oversight of clinical research activities.

Poland Romania Serbia Slovakia Hungary Full-time Entry Level Project Coordinator
1 hour, 49 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers