Field Clinical Research Associate

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.

Responsibilities

• 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.
• Cover coordination with the in-house team to provide ongoing site support.
• Cover coordination 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).

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 Competencies

• 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

Benefits

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.