Clinical Trial Associate (CONTRACT)

The Organization

What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. 

Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA- and protein-based programs for the potential treatment of neuromuscular and ocular diseases, among others.

Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.

We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.

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 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 operations team in the day-to-day operations, study start up and 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 proper 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, from study start-up to close-out.
• Provides accurate and up-to date clinical trial information within relevant tracking tools and provides regular updates of trial progression to the clinical trial team, including those related to protocol deviations, adverse events, and site personnel trainings.
• Contribute to the development of trial related plans and manuals.
• Ensures timely maintenance of the TMF, filing and reconciliation according to regulatory guidance and internal SOPs.
• Participates and ensures appropriate documentation of clinical team meetings, including meeting minutes, agendas, and action items.
• Manage vendor POs and trial payments (including budget reconciliation), including invoice review and approval.
• Support the set-up and management of clinical trial supplies and biosample management where needed (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 with at least 2+ years of relevant experience in clinical operations working at a biotech or pharmaceutical company.
• Strong understanding of clinical trial operations, including all phases from study start-up to close-out.
• Ability to work independently and take initiative on projects under minimal supervision.
• General working knowledge of drug development and ICH/GCP guidelines is required.
• Previous CRO or vendor management experience preferred.
• Excellent interpersonal, written, administrative, and computer skills.
• Excellent verbal and written communication skills with a strong attention for detail.
• Ability to travel app