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.

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

Transcend Therapeutics

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