Job Description

Job description:

Title

: Sr. Clinical Research Associate (CRA) - Site Monitor (Level II - Senior CRA)

Reports To:

Senior Director, Clinical Operations

Travel:

Up to 60% travel to investigative sites

Full-time contract role

Who We Are

: NX 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 that aids surgeons in tumor visualization during surgery. Our team prioritizes excellence and collaboration, and we are seeking a Sr. Clinical Research Associate to contribute to our mission.

Position Overview

: The Sr. Clinical Research Associate supports Clinical Operations projects, site management, and monitoring activities. This role requires a cross-functional skill set with strong attention to detail for timelines and site management. The Sr. CRA will perform quality and compliant site monitoring and management in accordance with industry best practices (ICH GCP) and procedures set forth by NXDC across all stages of clinical study development, execution, monitoring, and closeout. The Sr. CRA will perform both on-site and remote monitoring to ensure subject safety, the highest level of data integrity, and contribute to proactive risk management and inspection readiness.

This role will collaborate closely with key cross-functional internal stakeholders, including Clinical Operations, Medical Monitoring, Data Management, external CRO and vendor partners, Clinical Compliance, and Quality Assurance, to guarantee quality study oversight from study start-up through close-out

Primary 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. Oversee clinical trial data monitoring activities and provide CRO oversight to ensure quality, compliance, and timely deliverables. 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.

Education

:

B.S./B.A. in a scientific or clinically relevant discipline. Advanced degree (Master/PhD/MBA) in a scientific, clinical, nursing, or business-relevant discipline is preferred.

Experience and Core Competencies

:

Minimum of 5 years of monitoring experience as a Clinical Research Associate, including independent on-site monitoring responsibilities.

Experience in Surgical/Oncology/CNS/Optical Imaging Agents. 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.
Medical Specialty Focus:

Neurology Oncology
Job Types: Full-time, Contract

Pay: $130,000.00 - $140,000.00 per year

Work Location: Remote