NX Development Corp. · 22 hours ago
Sr. Clinical Research Associate
United States
Full-time
Remote
Senior Level
5+ years expNX Development Corp. is a dynamic and innovative organization committed to enhancing patient outcomes and advancing research and development in the use of Gleolan®, a real-time imaging agent. The Sr. Clinical Research Associate supports Clinical Operations projects, site management, and monitoring activities, ensuring compliance with industry best practices and contributing to proactive risk management.
BiotechnologyHealth CareHealth DiagnosticsTherapeutics
Responsibilities
Lead the review of essential clinical documents, including Clinical Protocols, Informed Consent Forms, Case Report Forms (CRFs), Site Training Materials, DOAs, study-specific logs, ISF binders, AEs/SAEs, and protocol-specific deviations
Conduct Pre-Study, Initiation, Interim, and Closeout monitoring visits following NXDC’s SOPs, regulatory requirements, and industry guidelines (ICH GCP)
Ensure trial data meets ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) data integrity guidance principles
Maintain site audit readiness and confirm the Informed Consent Process is well documented
Adhere to the approved Clinical Monitoring Plan and prepare monitoring reports and letters on time
Assist with data collection processes, ensuring site compliance, patient data integrity, edit checks, query resolution, and resolving data management issues
Ensure preparation, collection, and distribution of trial master file (TMF) documents and maintenance of regulatory files at investigative sites
Support internal departmental quality compliance and document accountability and storage conditions of clinical trial materials
Perform investigational product inventory reconciliation and ensure the return or destruction of unused materials
Support the design, implementation, and evaluation of recruitment strategies for study participants and ongoing monitoring of accrual rates
Assist with, attend, and may present at Investigator Meetings for assigned studies
Conduct periodic site file audits to ensure compliance with GCPs and NXDC standard operating procedures, requiring travel to investigative sites up to 65%
Perform activities in compliance with corporate and clinical operations policies, standard operating procedures, and work instructions
Other duties as assigned by management
Qualification
Required
B.S./B.A. in a scientific or clinically relevant discipline
Minimum of 5 years of monitoring experience as a Clinical Research Associate, including independent on-site monitoring responsibilities
Strong knowledge of clinical research processes, medical terminology, and GCP/ICH regulations
Proficiency in web-based data collection applications and compliance
Experience in clinical study development, including protocol development, study initiation, conduct, closeout, and regulatory filings
Proficient in Electronic data capture (EDC) systems, CTMS, eTMF and other clinical trial platforms
Knowledgeable in Phase I-III clinical trials
Proficient with Microsoft Office suite
Strong communication skills for various professional levels, including investigators, site staff, and internal staff
Ability to prioritize work, meet deadlines, and adapt to a fast-paced environment
Excellent organizational skills and attention to detail
Ability to work independently and within a team
Understanding of the healthcare environment and key external stakeholders
Preferred
Advanced degree (Master/PhD/MBA) in a scientific, clinical, nursing, or business-relevant discipline
Experience in Surgical/Oncology/CNS/Optical Imaging Agents
Company
NX Development Corp.
NX Development is a life sciences company that develops real-time intra-operative imaging agents.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$2.51M2018-04-30Acquired
2016-05-27Series Unknown· $0.7M
2015-03-12Series Unknown· $1.81M
Leadership Team
Alan Ezrin
Chairman & CEO
William Grieco
Senior Vice President, Legal and Compliance
Recent News
2025-12-19
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