Note: The job is a remote job and is open to candidates in USA. Transcend Therapeutics is a late-clinical-stage neuroscience company focused on developing rapid-acting treatments for neuropsychiatric diseases. The Field Clinical Research Associate will monitor site data for clinical trials, ensuring compliance with regulatory requirements and Good Clinical Practice while supporting site operations and training other CRAs as needed.
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
- 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
Skills
- 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
- Proficient knowledge of GCP/ICH, drug development process, clinical operations
- 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
- Domestic travel is required (approximately 75%)
- Strong understanding of clinical quality assurance principles and practices
- Experience in conducting studies in psychiatry-related indications
Benefits
- For full-time roles, we offer competitive cash and equity compensation; medical, dental, and vision insurance; 401k; unlimited vacation and sick time; and more.
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