Transcend Therapeutics · 1 month ago
Field Clinical Research Associate
United States
Full-time
Onsite
Mid Level
4+ years expTranscend Therapeutics is a late-clinical-stage neuroscience company developing 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 the in-house team and training other CRAs as needed.
BiotechnologyHealth CarePharmaceutical
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
Qualification
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
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%)
Preferred
Strong understanding of clinical quality assurance principles and practices
Experience in conducting studies in psychiatry-related indications
Benefits
Competitive cash and equity compensation
Medical, dental, and vision insurance
401k
Unlimited vacation and sick time
And more
Company
Transcend Therapeutics
Transcend Therapeutics offers novel pharmaceuticals for the critical care market.
2-10 employees
Funding
Current Stage
Early StageTotal Funding
$40MKey Investors
U.S. Department of Defense
2024-10-28Convertible Note
2023-09-21Grant
2023-02-23Series A· $40M
Leadership Team
Blake Mandell
Co-Founder and CEO
Kevin Ryan
Co-Founder and Chairman
Recent News
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