Field Clinical Research Associate

Field Clinical Research Associate

Remote

Position Details

Title: Field Clinical Research Associate

Type: Contract or Contract-To-Hire

Location: Regionally based (priority to hire East Coast and Central)

Company Overview

Founded in 2021, Transcend Therapeutics is a late-clinical-stage neuroscience company developing rapid-acting treatments for neuropsychiatric diseases. Our lead asset TSND-201, a rapid-acting neuroplastogen, is the first and only product to demonstrate rapid, robust, and durable therapeutic effects in PTSD. TSND-201 was granted Breakthrough Therapy designation by the FDA based on Phase 2 results, and we have aligned on a Phase 3 program for TSND-201 in PTSD. Transcend is backed by leading life sciences investors and driven by a mission to create treatments for the millions of people for whom current psychiatric medicines have not worked.

About the Role

The Field Clinical Research Associate (CRA) is a member of the Clinical team, with responsibilities for monitoring site data of one or more clinical trials and ensuring sites are compliant with applicable regulatory requirements and Good Clinical Practice.

A successful CRA is detail oriented, makes risk-based decisions, takes initiative, and keeps an eye on the big picture while focusing on the details.

Key responsibilities will include:

• Perform on-site monitoring visits, such as evaluation visits, SIV, IMV, and COVs along with timely and comprehensive site visit reports.
• Ensure site maintains an accurate inventory and accountability of investigational drug and clinical supplies.
• Ensure sites are conducting the study according to the protocol with high-quality data collection processes and excellent attention to patient safety.
• Coordinate with the in-house team to provide ongoing site support.
• Coordinate with the in-house team to maintain site compliance with study timelines, metrics, and plans.
• Identifies and communicates trends, risks, and deviations. Facilitate resolution of problems, queries and action items including identification of cause and actions to prevent recurrence.
• Support and train other CRAs, as needed.
• Support the in-house team as needed (eg, recruitment strategies, UAT of CRFs, remote data review).
• All other duties as required.

This is a great opportunity to step into a high-impact, high-visibility role on the early team of Transcend Therapeutics. For full-time roles, we offer competitive cash and equity compensation; medical, dental, and vision insurance; 401k; unlimited vacation and sick time; and more.

Experience Requirements

• Bachelor's degree, preferably in a life science
• At least 4 years of clinical trial experience within a pharmaceutical company or CRO, including at least 2 years of on-site monitoring experience and experience with risk-based and hybrid monitoring models.
• Strong understanding of clinical quality assurance principles and practices is preferred
• Experience in conducting studies in psychiatry-related indications is preferred
• Proficient knowledge of GCP/ICH, drug development process, clinical operations

Key Competency Requirements

• Excellent verbal, written, communication and interpersonal skills
• Detail-oriented, with a desire to 'get in the weeds' and understand the nuances
• Flexible, able to pivot when needed
• Able to proactively communicate and effectively collaborate across functions and job levels
• Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
• Internally motivated, with a passion for mental health
• Routinely takes initiative

Travel Required

• Domestic travel is required (approximately 75%)

We are committed to building a diverse, inclusive and talented team, free from discrimination. If you're excited about our mission but don't meet 100% of the qualifications above, we encourage you to apply.

Transcend Values

Operate with good intent. Above all, we aim to reduce suffering. We must remain selfless in pursuit of that noble goal, acting with good intent and assuming the same in our partners and peers.

Proceed with Passion. We're working to usher in an era where people with mental illness have safe and easy access to the treatments they need. Fulfilling that mission demands creative ideas, camaraderie among collaborators, and an understanding that we are all responsible for our individual and team success.

Be willing to work—and learn—together. The problems we're working to solve are complex, and no one person has every solution. Making the best decision as a team is more important than being individually 'right.' The diversity of our backgrounds and experiences is a strength; when all of those views are synthesized, we can develop new solutions and make better decisions.

Stay focused and flexible. Resourcefulness plays a major part in our success; we can't let unexpected set-backs derail our progress. Think creatively, act ethically, and find a way to get it done.