The Perfect Addition to Our Team

You are patient focused and excited about the opportunity to help support and develop the Clinical Operations organization at Entrada. You also enjoy a fast-paced environment and juggling competing priorities. You follow up and follow through, connecting problems with solutions efficiently. You work successfully in a team environment with strong interpersonal skills to effectively build working relationships inside and outside the company. 

The Opportunity

This individual will assist the Clinical Trial Lead and the clinical team in the day-to-day operations, set-up, execution, and closeout of assigned trials. The individual is accountable to the clinical trial team for the support of trial execution and works collaboratively with cross-functional team members and vendors to ensure proposer set-up of trial processes and plans to execute the protocol in accordance with established SOPs and standards. 

Responsibilities

• Support the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with ICH/GCP guidelines.
• Assist/Oversee (when outsourced) the set-up of trials in relevant clinical trial systems (may include: TMF, CTMS, ct.gov, EUDRACT etc.).
• Provides accurate and up-to date trial information within relevant tracking tools and provides regular updates of trial progression to the clinical trial team.
• Assist in the development of trial related plans and manuals.
• Ensures timely maintenance of the trial master file.
• Participates and ensures appropriate documentation of clinical team meetings.
• Managed vendor Pos and trial payments (including budget reconciliation), may include invoice review/approval.
• Assist in the set-up and management of clinical trial supplies (drug product, ancillary and other).
• Assist in external training activities (suppliers, clinical sites etc.).
• Assist in the management of trial completion activities, including data review, database lock and trial closeout.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

• Humanity - We genuinely care about patients and about one another.
• Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
• Creativity - We are creative problem solvers.
• Collaboration - We are more than the sum of our parts.
• Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

• BA/BS degree or an associate degree with at 3 years of relevant experience.
• Excellent interpersonal, written, administrative and computer skills.
• Fluent in English (oral and written).
• General knowledge of drug development and ICH/GCP guidelines.
• Minimal (0-5%) travel required.